AddressJob Description Summary
This position will serve as the Quality Engineering lead for the Woburn Manufacturing facility. The primary responsibilities center on resolving manufacturing, QC, and Lab related issues by implementing effective solutions, revising facility documentation for accuracy and compliance, validating equipment/processes/product as needed, and identifying/implementing continuous improvement projects.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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
- Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components.
- Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel.
- Provide technical guidance to the staff and mentorship to quality and manufacturing engineers.
- Document risk-based rationales as needed throughout the Quality Management System.
- Write and implement validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
- Lead CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper efficiency verification methods.
- Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations.
- Represent the Quality function on committees, teams, task forces as assigned.
- Support the goals of the Quality Control Dept. and the Woburn Manufacturing facility.
- Supervise Lab personal, QC, and Document Control
- Special projects as assigned.
- Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
Minimum Educational Experience:
- Bachelors Degree in Engineering (Chemical, Mechanical or Biomedical preferred)
- 5-8yrs of medical device Quality Engineering experience
- Experience operating in GLP, GMP, and GDP
- Knowledge of statistics and experience with statistical software (ex: MiniTab)
Desirable Qualifications:
- Design Control and Risk Management experience with pharmaceutical, combination products, or medical devices
- ASQ Certified Quality Engineer (CQE) or advanced degree
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?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
SWE
PDN
