Quality Engineer I, Post-Market Surveillance
We are the people who give possibilities purpose
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.
Job Description
Job Responsibilities
- Lead and manage Post-Market Surveillance (PMS) activities, ensuring all reviews are completed on time and in compliance with applicable regulations, quality standards, and company procedures.
- Develop and maintain Post-Market Surveillance Plans and Reports, including:
- Gathering data from multiple internal and external sources
- Analyzing product performance and safety information
- Accurately documenting post-market findings
- Preparing clear summaries, conclusions, and recommendations
- Identify gaps, trends, and opportunities through PMS reviews and drive updates to product documentation as needed.
- Support and implement improvements to PMS processes, procedures, practices, and related documentation.
- Partner closely with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations teams to ensure timely completion of PMS activities and reviews.
- Build strong cross-functional relationships and collaborate effectively with stakeholders across the organization.
- Escalate critical issues, risks, or compliance concerns to management when appropriate.
- Ensure all work is performed in accordance with company policies, quality system requirements, and applicable global regulations.
Required Qualifications:
B.S. in Engineering, Science, or mathematics field.
Preferred Qualifications:
1-3 years experience in Post-Market Surveillance in the medical device industry
American Society of Quality (ASQ) certification(s) (CQE, CQA, etc.)
Knowledge and Skills:
Proficiency in writing detailed summary reports and experience in analyzing data to draw conclusions for reports.
Effective listening, questioning, problem solving, conceptual thinking, and analytic skills.
Ability to manage multiple assignments and projects concurrently.
Ability to participate in a cross-functional team environment and exercise influence to effectively collaborate and complete deliverables on time.
Basic understanding of product risk management and related deliverables (Risk Management Plan, Failure Mode and Effect Analysis, Benefit-Risk Analysis, Risk Management Report, etc.).
Basic knowledge and understanding of appropriate global regulations, requirements, and standards such as ISO 13485:2016, FDA Quality System Regulation, EU Medical Device Regulation (EU) 2017/745, SOR/98-282 Medical Device Regulations (Health Canada), ISO 14971:2019.
Basic knowledge of statistical techniques.
Proficient understanding of product risk management
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. 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.
Required Skills
Optional Skills
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