About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946. Abbott Ireland Diagnostic Division – Longford: The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid, and cardiovascular diseases. Longford is based in the midlands of Ireland surrounded by water with the River Shannon, Lough Ree and the Royal Canal. It has a vibrant collection of communities with a rich historical background. The County has plenty to offer to both visitors and citizens in sport, culture, literature, amenities, festivals, events, retail and dining. Position: Operations Specialist - Finishing PURPOSE OF THE JOB: Support the Manufacturing/Finishing processes within the Operations department through developing and maintaining expertise in a designated process or technical speciality. Ensure the plant meets its customer quality, service, regulatory, financial and safety goals through effective technical support of Diagnostic products. Provide necessary support to the Finishing Operations team, ensuring that production targets are attained. Manage all assigned projects to timely completion and deliver cost savings as agreed per project. KEY RESPONSIBILITIES: Develop Subject Matter Expertise, and take lead, in designated change control / process / technical speciality. Establish oneself as key contact for designated process. Provide necessary support to production schedule requirements as designated by Team Leader. Champion the principles and practices of GMP/GLP. Lead by example and provide mentoring support for team members. Lead and support process investigations in the finishing manufacturing area. Identify, initiate and execute to completion cost improvement projects. Challenge conventional wisdom by posing new ways of doing things and demonstrating the successful application of new methodologies. Minimise generation of deviations by ensuring that all relevant documentation is being followed and that verification steps are being completed accurately and objectively. Ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors, and other external agencies. Liaise with, seek appropriate advice from and report when necessary to colleagues in other sites. Assist in the periodic review of controlled documents per site procedures. Maintain ETMS To Do List. Responsible for technical transfer activities for the manufacturing/Finishing process as applicable through drafting/review of documents including protocols, MES recipes/Master data, Qualifications and Reports. Coordinate validation activities involving cross-functional, multi-departmental teams including Engineering, Manufacturing and Quality. Support product development activities by providing operational leadership to the team by giving technical support and recommendations of effective solutions to the Manufacturing/Finishing issues. EDUCATION & EXPERIENCE: A third level qualification in a relevant Chemistry or Life Science discipline or Engineering. Or a relevant professional qualification as this level of education provides a necessary foundation for this Job function. A minimum of 20 months experience in a regulated environment of which 12 months is in the manufacturing/testing or support of diagnostic products. Or a relevant post-graduate qualification with 12 months experience in the manufacturing/testing or support of diagnostic products. Or a relevant professional qualification, together with a minimum of 12 months experience of supporting the manufacture/test of diagnostic products. #J-18808-Ljbffr
Abbott Ireland Financial Services Cherrywood Dublin Abbott’s EMEA Finance Shared Services centre commenced operations in Cherrywood, Dublin in October 2015. From this location the Finance Shared Services provides processing and expertise, in local languages, to Abbott divisions and affiliate companies across EMEA. The core services are in Record to Report, Order to Cash, Source to Pay and Master data management. The Financial Shared Services hub is part of Corporate Finance and has regional counterparts in the US and in Singapore. Purpose of Job: Compliance Analyst will be accountable to perform the following activities for Corporate Financial Services (CFS) in the EMEA Region SOX Testing & Remediation Control Environment Maintenance & Improvements Audit Coordination & Support Division Security Coordination Support Support various CFS initiatives and strategic programs Minimum Education: BA, BS in Finance or Accounting or equivalent experience, CPA/ACCA/ACA preferred, however would consider part qualified. Minimum Experience: 2-3 years relevant industry experience would be an added advantage. Experience in SOX compliance is essential for the role. Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization Ability to work within a team and as an individual contributor in a fast-paced, changing environment Ability to leverage and/or engage others to accomplish projects Ability to multi-task, prioritize and meet deadlines in a timely manner Proficient with Microsoft Excel Main Responsibilities: SOX Testing & Remediation Perform Management SOX testing Identify deficiencies and develop management action plans Manage the outreach, analysis, and memo documentation of applicable SOC 1 reports Control Environment Maintenance & Improvements Enhance and maintain SOX documentation by working with process owners and shared service operations managers (e.g., flowcharts, risk assessments, etc.) Support management’s evaluations of internal control over financial reporting via the Archer tool Identify areas where internal controls can be optimized (e.g., shift toward preventive automated controls) and process improvements implemented Support enhanced compliance and testing of focus areas Audit Team Coordination and Support Support internal and external audit teams surrounding CFS controls, as well as attendance all relevant walkthroughs Identify opportunities to advance the CFS control reliance strategy between Internal and External Audit teams Partially supervise third-party resource to ensure control environment is operating effectively and testing is appropriately documented Division Security Coordinator Support Support the review and maintenance of regional system requests for segregation of duty conflicts across multiple ERPS Implement new mitigating controls and monitor the expiration of existing controls within SAP Environments Support CFS Initiatives and strategic programs Support ad hoc control projects, including those arising from unique events, transactions, mergers, acquisitions and system implementations that impact CFS Support ERP deployments – Design of controls, segregation of duties (SOD) concerns and mapping users to roles to avoid SOD issues Support other compliance areas including master data governance Perform other related duties and responsibilities that support CFS, reporting managers and associated teams Support other initiatives outside of compliance that improve and streamline efforts within the CFS organization #J-18808-Ljbffr
Are you looking for a new opportunity to gain experience in a global Shared Service Centre? We currently have a vacancy for a Senior Accountant who will work within the RTR team, looking after the European markets with our outsourced partners. This is an exciting opportunity for anyone who is a strong communicator looking to accelerate their career within a fast-paced environment, collaborate with cross-functional teams, and work both independently and as part of a dynamic team. The successful candidate will join the Shared Services Centre based in Cherrywood Business Park, Loughlinstown, Co Dublin. In this position, you will have the opportunity to problem-solve and drive process improvements. KEY REQUIREMENTS: Minimum Requirements: Accounting Qualification – ACA, ACCA, CPA, CIMA; Post qualified experience preferably with Shared Service Centre and multinational corporation background; however, open to practice experience with global clients. Strong sense of initiative in change management and process improvements. Fluency in French. Preferred Requirements: S4 Hana or other major ERP Systems experience is desirable. Experience with migration of activities to shared services. Strong Excel Skills are required for the role. Power BI or data analytics skills desirable. Duties & Responsibilities: Responsibility for the monthly general ledger close activities for US GAAP. Review and preparation of monthly reconciliations & journals to ensure high-quality compliance with US GAAP. Complete SOX controls in line with control matrix. Work closely with outsourced business partners. Maintain and develop relationships with key stakeholders and provide information and support as needed. Ensure timely completion of Internal and External audits. Provide input to and coordinate projects. Identify opportunities for improvement of processes and work on key team projects. Migration of activities to shared services. Standardization of processes post-migration to SAP and shared services. Benefits and Perks: Comprehensive benefits package inclusive of Pension and Healthcare. Share options. Luas stop right outside the building. Underground parking available. Onsite canteen. #J-18808-Ljbffr
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries. Abbott Ireland In Ireland, Abbott employs around 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946. Diabetes Care Kilkenny Our new manufacturing facility in Kilkenny reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies that enable people with diabetes to live the best and fullest lives they can. At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare. This is how you can make a difference at Abbott: As a CAPA Engineer, you will facilitate and execute the CAPA process. You will also support continuous improvement and effective maintenance of the QMS. Ensure the use of appropriate risk management tools to prioritise activities. Key Responsibilities Participate in the completion of CAPA projects, ensuring compliance, and quality of records. Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills). Independently investigate, gather data, and perform preliminary analysis. Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals. Identify trends, potential issues, and improvement initiatives. Ensure on-time completion of Quality Assurance engineering deliverables. Support the team in the delivery and oversight of CAPA training program. Identify projects to enhance and promote effectiveness and efficiency of the quality system and product quality. Support Operations to make Quality/Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging. Provide support and subject matter expertise during audits and inspections. Qualification and Experience Minimum Level 7 NFQ qualification or equivalent in a relevant discipline. Min of 4 years experience in Engineering/Manufacturing/Scientific environment. Previous CAPA and/or quality assurance/engineering experience. Ability to demonstrate use of quality tools/methodologies. Prior medical device experience preferred. Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016. Good communication and interpersonal skills. Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing skills. What we Offer Attractive compensation package that includes competitive pay, as well as benefits such as: Family health insurance, Excellent pension scheme, Life assurance, Career Development, Fantastic new facility, Growing business plus access to many more benefits. Abbott is an equal opportunities employer. #J-18808-Ljbffr
Technical (Scientific) Lead Apply locations Ireland - Donegal Town Time Type Full time Posted on Posted 4 Days Ago Job Requisition ID 31088709 JOB DESCRIPTION: Why will you enjoy this new opportunity? At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries. The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. In Donegal site we are recruiting a Technical Program Manager to drive continuous improvement and innovations. As a senior member of the Technical Scientific team of 90 you will report directly to the Department Leader working on new products/technologies. Your role will involve: Develop and manage technical change projects to enhance department efficiency and capability, aligning with business needs. Demonstrate effective leadership, planning, investigation, and communication skills. Collaborate with R&D, Site and Division Technical and Engineering, and Site and Division Quality Assurance to represent the site technically in both daily operations and long-term commitments. Achieve project/program financial targets in support of business objectives. Analyse complex processes and problems to identify areas of improvement and risk. Oversee the work of others and provide mentoring in technical or organizational areas. Report out to all levels of the organization. Education, Experience and Skills: A relevant third level qualification, preferably in Science. Previous experience in a Medical Device or Pharmaceutical industry demonstrating role progression. 3-5 years team leadership experience. Skilled in effective management, planning, investigation and communication. Demonstrate initiative and roll out of new ideas. Strong technical decision-making and problem-solving skills, demonstrated good judgement. What are the benefits and perks of this job at Abbott Donegal? Excellent career path opportunities. Health Insurance for you and your family. Pension. Life insurance. Short Term Disability Protection. Long Term Disability Protection. Carers leave. Education Assistance. The base pay for this position is: N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Engineering DIVISION: ADC Diabetes Care LOCATION: Ireland > Donegal Town : R267 ADDITIONAL LOCATIONS: WORK SHIFT: Ie - Shftpre0 (Ireland) TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable About Us Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. Description The global Design Assurance team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports R&D, Marketing, Clinical Operations, RA, QA and manufacturing functions based in Europe, Asia and US. The team is responsible for Design Control throughout the lifecycle of NPI projects, from ideation through to product launch including sustainment, for realization of our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott. To ensure we can rapidly expand our Design Assurance capability, we are recruiting a Senior Design Assurance Engineer that will strengthen the team through implementation of best practice design controls and support the Organisation as a whole to maintain those within our projects. The Senior Design Assurance Engineer role will be instrumental in shaping the Design Control strategy to support our IDEM new product development pipeline. They will drive improvement in our processes, provide direction to and ensure compliance across all our supporting organisation – R&D, Marketing, QA, RA, Clinical Operations and Manufacturing. The specific role initially will be focused on a number of exciting new product development opportunities across our Manufacturing Plants, and partnering with our R&D teams to support the design control process to deliver the required design phase outputs. Responsibilities and Duties Design and development of packaging labelling and labelling solutions for New Product Introduction (NPI) and legacy products, including IFU’s. Participate in / lead cross-site, cross-function labelling related projects and activities. Generate project design assurance documentation and update label-related documentation as required. Communicate with various departments, functions and sites within Abbott on labelling related projects. Development of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams and relevant functions within the Business Unit. Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze. Provision of on-going risk management, design control, quality systems and overall design assurance labelling expertise and leadership to the Project Core and Extended teams. Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes. Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits. Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader. Requirements Primary Degree level qualification in Science, Engineering or Technology, plus 5 years of Quality Engineering/ Design Assurance/ Regulatory Affairs work experience within a regulated environment (ISO13485/ FDA). Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem Solving would be beneficial. Excellent data analysis skills. Proven ability to work well as part of a team and on own. Excellent communication skills to support virtual project requirements. Clear demonstrated experience in working in a diverse cultural environment. Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management. Travel pending company policy, global and country regulations to Asia and Europe. #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world in diagnostics, nutrition, cardiovascular, medical devices, and branded generic pharmaceuticals, creating more possibilities for people at all stages of life. Today, our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. 12 Month FTC Description The global Design Assurance team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports R&D, Marketing, Clinical Operations, RA, QA, and manufacturing functions based in Europe, Asia, and the US. The team is responsible for Design Control throughout the lifecycle of NPI projects, from ideation through to product launch, including sustainment, for our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott. To ensure we can rapidly expand our Design Assurance capability, we are recruiting a Senior Design Assurance Engineer who will strengthen the team through the implementation of best practice design controls and support the organization as a whole to maintain those within our projects. The Senior Design Assurance Engineer role will be instrumental in shaping the Design Control strategy to support our IDEM new product development pipeline. They will drive improvement in our processes, provide direction, and ensure compliance across all our supporting organizations – R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing. The specific role will initially focus on a number of exciting new product development opportunities across our Manufacturing Plants and partnering with our R&D teams to support the design control process to deliver the required design phase outputs. Responsibilities and Duties Promote awareness of regulatory and customer requirements throughout the organization. Review and remediate current Design Control procedures and practices across sites to standardize to “best in class” design controls. Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure compliance and drive alignment and harmonization. Develop effective training collateral to ensure compliance with design control policies within the Core Teams, Extended teams, and relevant functions within the Business Unit. Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development, and provision of statistical sampling to ensure robust prototypes and design at design freeze. Support new test development and appropriate test method validation. Provide ongoing risk management, design control, quality systems, and overall design assurance expertise and leadership to the Project Core and Extended teams. Perform technical reviews of design documentation and labeling, attend design reviews, coordinate and facilitate completion and update of design risk management documentation, and act as an independent reviewer for all design activities including design changes. Provide Design Control Support for audits, including Abbott Corporate Audits and external Regulatory/Governing Body audits (e.g., FDA/WHO). Lead the team’s participation in audits. Manage a team of Design Assurance Engineers as the organization grows and develops. Work effectively in a matrix organization where project deliverables are accountable to the Program/Workstream Leader. Requirements Primary degree level qualification in Science, Engineering, or Technology, plus 5 years of Quality Engineering/Design Assurance work experience within a regulated environment (ISO13485/FDA). Formal training in Medical Device Risk Management, Process Validation, Software Validation, and problem-solving would be beneficial. Excellent data analysis skills. Proven ability to work well as part of a team and independently. Excellent communication skills to support virtual project requirements. Demonstrated experience in working in a diverse cultural environment. Excellent presentation skills to facilitate communication throughout the organization, along with proficiency in virtual communication technology for effective workshop leadership and change management. Travel pending company policy, global, and country regulations to Asia and Europe. #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. Description The position of Senior Program Manager is within our Infections Disease (ID) business unit located in Galway, Ireland. This role will manage end to end IVDR. Senior Program Manager will report directly to Director, Program Management, IVDR in the PMO Office. Responsibilities and Duties Lead the transition from IVDD to IVDR as part of the EU regulation change. Strategy developer with cross functional team and translation of strategy into program/project plans, including timelines, budgets, and resourcing requirements; continually tracks progress against those plans. First designate to Director, responsible for reporting activities, collecting and collating inputs from cross functional teams to support project reviews with relevant stakeholders. Identifies and escalates project risks and communicates on project status to Director. Assists the Director in structuring the team and program. Proactively leads program milestones and effectively communicates cadence to ensure timely dissemination of information to Director, leadership, program/project teams and stakeholders through regular governance meetings. Key contributor in structuring the program, focusing on efficiency gains, whilst complying with governing regulations. Key contributor in the generation of progress reports for delivery to Director, leadership and stakeholders. Self-driven individual, team contributor and key inputter into capacity assessments (people, financial measures) to meet plans and timelines. Highlights gaps and drives resolution with functional leaders. Coaches program team members to ensure a comprehensive, integrated program strategy is delivered and is responsible for generating formal training materials and leading education sessions for applicable functional areas and regions. Responsible for the oversight of 80 products for Regulatory Submission, Implementation and Post Market Surveillance. Responsible for driving continuous improvement. Working globally across 6 manufacturing sires, across different language Ensures cross functional members work as a ‘team’, focused on business goals and offers solutions to program challenges. Responsible for Hiring, Onboarding and Managing Direct Head Count (FTEs/Contractors). Requirements A bachelor’s degree which could include supply chain, engineering, science, IT or equivalent business disciplines. 10 or more years of experience in Project Management, Operations, Manufacturing, Supply Chain, Quality/Regulatory or related function, preferably in medical device, pharmaceutical or consumer products. Preferred Qualifications One or more professional certifications or equivalent experience (e.g., PMP) Competencies Exceptional project management skills, with proven ability to clearly define objectives and priorities, establish milestones, anticipate and mitigate risks, lead cross-functional teams to meet and exceed goals in a dynamic environment, while maintaining strong attention to detail and quick recall Experience managing with ambiguity; demonstrated ability to take ownership of problems, exercise sound judgment and independently determine appropriate course of action where precedent may not exist Strong communication skills – in English in written and verbal; briefing, presentation, education/training skills Able to influence without authority Ability to work in a highly matrixed and geographically diverse business environment Ability to create & manage a vision, think strategically, plan and organize, innovate, analyse complex data and situations, and exercise sound judgment. #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. 12 month FTC Description The global Design Assurance team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports R&D, Marketing, Clinical Operations, RA, QA and manufacturing functions based in Europe, Asia and US. The team is responsible for Design Control throughout the lifecycle of NPI projects, from ideation through to product launch including sustainment, for realization of our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott. To ensure we can rapidly expand our Design Assurance capability, we are recruiting a Design Assurance Engineer that will strengthen the team through implementation of best practice design controls within our projects. The Design Assurance Engineer role will be instrumental in shaping the NPI Project deliverables to support our IDEM new product development pipeline. They will provide direction to and ensure compliance across all our Core Teams and Extended Teams – R&D, Marketing, QA, RA, Clinical Operations and Manufacturing. The specific role initially will be focused on a number of exciting new product development opportunities and participate on cross-site or cross Business Unit Core Teams to ensure standardisation of project deliverables in compliance with best-in-class design controls. Responsibilities and Duties Promotes the awareness of regulatory and customer requirements throughout the organization. Remediation of current Design Control procedures and practices across sites to standardise to “best in class” design controls. Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization. Deployment of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams and relevant functions within the Business Unit. Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze. Support new test development and appropriate test method validation. Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams. Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes. Escalate where appropriate design control concerns/ issues in a timely manner to ensure project schedule maintenance. Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader. Requirements Primary Degree level qualification in Science, Engineering or Technology, plus 2-3 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA). Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem Solving would be beneficial. Excellent data analysis skills. Proven ability to work well as part of a team and on own. Excellent communication skills to support virtual project requirements. Clear demonstrated experience in working in a diverse cultural environment. Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management. Travel pending company policy, global and country regulations to Asia and Europe. #J-18808-Ljbffr
About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. Description The position of Program Lead is within our Infections Disease (ID) business unit located in Galway, Ireland. This role will lead end to end IVDR. Program Lead will report directly to Director, Program Management, IVDR in the PMO Office. Responsibilities and Duties Lead the transition from IVDD to IVDR as part of the EU regulation change. Liaising with cross functional team to drive program/project plans, including timelines, budgets, and resourcing requirements; continually tracks progress against those plans. Responsible for reporting on assigned activities, collecting and collating inputs from cross functional teams to support project reviews with relevant stakeholders. Identifies and escalates project risks and communicates on project status to Manager. Proactively leads program milestones and effectively communicates cadence to ensure timely dissemination of information to management, program/project teams and stakeholders through regular governance meetings. Key contributor in structuring the program, focusing on efficiency gains, whilst complying with governing regulations. Key contributor in the generation of progress reports for delivery to management and stakeholders. Self-driven individual and team contributor responsible for highlighting gaps and drives resolution with functional leaders. Assists coaching program team members to ensure a comprehensive, integrated program strategy is delivered and assists generating formal training materials and delivering education sessions for applicable functional areas and regions. Responsible for leading 80 products for Regulatory Submission, Implementation and Post Market Surveillance. Responsible for driving continuous improvement. Working globally across 6 manufacturing sires, across different language barriers. Ensures cross functional members work as a ‘team’, focused on business goals and offers solutions to program challenges. Assists Hiring, Onboarding with potential to manage Direct Head Count (FTEs/Contractors). Requirements A bachelor’s degree which could include supply chain, engineering, science, IT or equivalent business disciplines. 8 or more years of experience in Project Management, Operations, Manufacturing, Supply Chain, Quality/Regulatory or related function, preferably in medical device, pharmaceutical or consumer products. Preferred Qualifications One or more professional certifications or equivalent experience (e.g., PMP) Competencies Exceptional project management skills, with proven ability to clearly define objectives and priorities, establish milestones, anticipate and mitigate risks, lead cross-functional teams to meet and exceed goals in a dynamic environment, while maintaining strong attention to detail and quick recall Experience managing with ambiguity; demonstrated ability to take ownership of problems, exercise sound judgment and independently determine appropriate course of action where precedent may not exist Strong communication skills – in English in written and verbal; briefing, presentation, education/training skills Able to influence without authority Ability to work in a highly matrixed and geographically diverse business environment Ability to create & manage a vision, think strategically, plan and organize, innovate, analyse complex data and situations, and exercise sound judgment #J-18808-Ljbffr
