A leading medical device company in Galway is seeking a Senior Quality Systems Engineer. This hands-on role includes ownership of the site Quality Management System, ensuring compliance with industry standards such as ISO 13485 and FDA regulations. The ideal candidate will have over 5 years of experience in quality roles within the medical device industry, and will work collaboratively to integrate the acquiring company's global QMS, ensuring effective operations while building a strong quality culture on site. #J-18808-Ljbffr
About the Role / Job Description Senior Quality Systems Engineer – Galway, supporting a growing medical device business as it transitions from a start‑up environment into a scaled, high‑volume operation. This hands‑on role involves taking ownership of the site Quality Management System , ensuring it remains compliant, effective, and fit for purpose. In parallel, you will play a key role in the integration of a global QMS following acquisition, helping to align ways of working while maintaining the agility and strengths of the existing site. You’ll work closely with both local teams and global stakeholders, with real opportunity to influence how quality systems evolve on site. Essential Duties Ownership of the site QMS , ensuring ongoing compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR Lead and support core QMS processes including: CAPA Change Control Nonconformance Management Document Control Internal Audits Management Review Maintain a state of audit readiness , supporting notified body and regulatory inspections Act as a go‑to QMS subject matter expert on site Support and lead elements of the integration of the acquiring company’s global QMS Carry out practical gap assessments and help define how best to align systems and processes Develop and execute clear, phased integration plans , with a focus on maintaining compliance and minimising disruption to operations Work with global teams to harmonise procedures and systems , while ensuring they are workable at site level Apply risk‑based thinking to QMS updates and integration activities Partner with Operations, R&D, Regulatory, and Supply Chain to ensure QMS processes are understood and effectively applied Provide day‑to‑day support and development to direct report(s) Contribute to building a strong quality culture across the site Identify opportunities to simplify and improve QMS processes , particularly as the site scales Qualifications Education Degree in Engineering, Science, or a related discipline Experience 5+ years’ experience in a Quality role within the medical device industry Strong working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR Experience maintaining and improving a practical, working QMS in a manufacturing environment Exposure to QMS integration, harmonisation, or significant change activities would be a strong advantage Previous experience mentoring or supporting engineers is desirable Skills / Strengths Practical, hands‑on approach to quality systems Strong understanding of how QMS works in a real manufacturing environment Ability to balance compliance requirements with operational realities Good communicator, comfortable working across functions and levels Organised, with a focus on delivering clear, workable solutions Problem Solving Highly thorough and dependable Independent in task execution. Meticulous, focus and attentive to details and accuracy in all aspects of the job Positive attitude, able to influence and lead different groups of employees, motivate and guide people toward organisational success Analytical minded, resourceful, data driven, using quality tools and methodology to deliver results Training/Certifications International standards: ISO13485, ISO19011, ISO14971 Regulatory laws: 21CFR820, 21CFR11, 21CFR803, GDPMD, Malaysia Medical Device Act 2012, Canadian MDR, EU Directive 2007/47/EC, MHLW Ord. 169, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745). Physical Demand Sit; use hands to finger, handle, or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Lifting/moving up to 10 pounds. Exposure to moving mechanical parts, vibration and/or moderate noise levels. Exposure to hazardous chemicals or other materials. EEO Policy Statement #J-18808-Ljbffr
A leading medical device company in Galway is seeking a Senior Manufacturing Manager to achieve production objectives across various product lines. The role requires a hands-on approach to lead teams, drive continuous improvements, and ensure compliance with quality standards. The ideal candidate will have over 10 years of experience in medical device manufacturing and strategic vision blended with problem-solving skills, fostering a high-performance culture on-site. #J-18808-Ljbffr
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Overall Job Objectives As Senior Manufacturing Manager, you will be responsible for ensuring company Production objectives are achieved for all commercial, NPD and technology transfer products. You will be a key member of the leadership team, collaborating cross-functionally to drive product quality, manufacturing efficiency, innovation, and commercial success. With a hands‑on approach, you will lead from the front, fostering a high‑performance culture while ensuring compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and the Vivasure Medical Quality Management System. This role is an on‑site based role. Main Duties and Responsibilities Lead the Production Teams to achieve output, delivery, quality and cost targets. Manage, coach, motivate and develop the Production team. All Production planning to meet customer and company requirements. Implement smart metrics, tracking and reporting for manufacturing KPIs inc. line outputs, yields, scrap. Plan capacity and ensure adequate resources are in place to successfully deliver the production department goals. Drive continuous improvement plans in Production using lean manufacturing approach with focus on safety, quality, productivity and cost. Technology transfers to Production and implementing new products and technologies to high yield, scalable manufacturing. Implementation and completion of QMS documentation for Production. Provide design for manufacturing expertise for NPD process development teams. Qualification Required Bachelor’s Degree in an engineering or technical discipline (or equivalent experience). 10+ years of progressive experience in medical device manufacturing, ideally within Class III implantable devices. Knowledge of quality standards including ISO 13485, MDR, and FDA Requirements. Work Experience or Training Required Demonstrated team building, problem solving, continuous improvement and cost reduction achievements in Production and related areas. Proven ability to blend strategic vision with a hands‑on, problem‑solving approach. Strong experience in operational excellence and lean manufacturing. Entrepreneurial mindset with a commercial awareness to align manufacturing with business objectives. Excellent communication and documentation skills. Ability to manage multiple priorities in a fast‑paced production environment. Special Skills Required Proficient in process improvement tools such as Lean, Six Sigma (Green Belt is an advantage). EEO Policy Statement #J-18808-Ljbffr
