Job Description Summary As a Design Assurance Quality Engineer (QE), you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards.
Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.
Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements.
Your responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross-functional teams and effective communication skills.
You will lead risk management activities, manage Design History File (DHF) documentation, and support compliance initiatives such as IEC 60601 and IEC 62304.
The role involves reviewing and approving verification and validation plans, challenging statistical rationales, and authorizing deviations.
You will also assist in failure investigations, software issue tracking, and advocate for a strong quality culture across projects.
Additionally, you will contribute to broader Quality Management System (QMS) activities, including CAPA, field assessments, and operational engineering evaluations.
Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world.
Advancing the world of health is our Purpose, and it's no small feat.
It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.
You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health.
At BD, you'll discover a culture in which you can learn, grow and thrive.
And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us! Our vision for Medication Management Solutions at BD With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.
About the role As Quality Engineer
- Design Assurance, you will be involved in new product development and product sustaining projects through the application of Quality Engineering skills.
You will balance multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.
You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements.
The Design Assurance QE represents the Quality Function on the Project core teams for both new product development and existing products.
Main responsibilities will include: Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
Contribute to the formation and ongoing management of DHF documentation Lead risk management activities within the project.
Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
Demonstrate a patient-first approach to quality engineering.
Support the creation and implementation of verification and validation activities.
Work closely with R&D functions to ensure comprehensive testing of product requirements and the execution of the V&V plan.
Review and approve testing procedures and documentation.
Review and challenge the statistical rationale and data analysis within the test protocol and reports.
Assess and authorise related execution deviations.
Assist/conduct Failure investigations and problem-solving sessions.
Responsible for the software issue tracking process per IEC 62304 to ensure software issues are logged, risk assessed and dispositioned appropriately.
Ensure compliance across projects for design control, risk management, and change control processes.
Advocate for a strong quality culture within project core teams Support of other QMS activities outside of projects, such as CAPA, Field Assessment and operations engineering assessments.
About you A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years of quality engineering experience as an equivalent qualification Knowledge in working with ISO 13485, QSR, ISO 14971, and statistical techniques Expertise in design assurance, including design controls, standards compliance, and risk management Strong written and verbal communication skills Strong organisational skills Experience with MDR
- advantage Experience with IEC 62304 and IEC 62366
- advantage Ability to influence.
Assess the situation and determine if a blocking issue is triggered.
Click on apply if this sounds like you! At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.
For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Becton, Dickinson and Company is an Equal Opportunity Employer. xsokbrc
We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
