Quality Manager, EMI Quality Excellence
Becton Dickinson
This listing was originally posted on Becton Dickinson's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
Drug products linked to this role
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.
Key responsibilities
Develop, maintain, and oversee EMI wide quality assurance programs, policies, and procedures.
Harmonize quality management system (QMS) processes across EMI plants to ensure consistency, compliance, and effectiveness.
Support EMI sites during internal, external, and regulatory audits; conduct site visits and provide hands on audit preparation and remediation guidance.
Assist plants in defining, implementing, and improving quality system best practices aligned with corporate quality standards.
Lead manufacturing quality initiatives, driving timely resolution of quality issues across all EMI sites.
Manage and support product realization activities, including line transfers, design transfers, and New Product Development (NPD) introductions into manufacturing.
Ensure manufacturing readiness for design & manufacturing transfers, including compliance with RoHS and applicable regulatory or technical requirements.
Support process validation and verification, risk management, and alignment of upstream design controls with downstream manufacturing processes.
Support EMI plants with supplier oversight including but not limited to: SCAR issuance and follow up, Supplier related nonconformance (NC) investigations and critical issues, CAPA development, review, and closure, Supplier Corrective Requests (SCR), Essential Partner engagement, and change controls, provide feedback to plant level Management Review.
Partner closely with CMOs, parts/material suppliers, and internal categories to ensure supplier accountability and performance.
Raise systemic supplier issues as appropriate to Category Management.
Lead or support cost and quality improvement initiatives across EMI sites, including:
First Pass Yield (FPY) improvements
Cost of Goods (COGs) reduction
Cost to Win (CTW) initiatives
Cross‑plant process improvements and harmonization
Facilitate data‑driven root cause analysis and cross‑functional problem‑solving.
Work closely with Business Units and Central Quality to align and standardize processes across EMI.
Serve as a subject matter expert for manufacturing quality, supplier quality, and product realization.
Coordinate with engineering, operations, design, and regulatory stakeholders to ensure seamless quality integration.
Lead a team of supplier quality engineers implementing plant level initiatives and projects.
Complete additional tasks and pivotal initiatives as assigned by the Associate Director of EMI Quality Excellence.
Approximately 10–25% travel to EMI manufacturing sites, as required.
Education
Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
Experience
Minimum 5 years of experience in Quality Engineering, Supplier Quality or similar roles, in the following areas: Electromechanical Instrumentation, Quality Assurance, FDA QSR’s, Lean Manufacturing, Risk Management (ISO 14971), and ISO/IEC (MDD/MDR, MDSAP, CMDR, ISO 13485, JPAL).
Minimum 5 years of experience leading a team.
Required Knowledge and Skills
Demonstrated expertise in manufacturing processes, quality systems, and product realization workflows.
Strong experience with design controls, process validation, and NPD/NPI integration to manufacturing.
Experience leading Change Control, SCARs, CAPAs, and root cause analysis.
Ability to manage and lead cross‑functional initiatives across global locations.
Lead Auditor certification (ISO 9001, ISO 13485, or equivalent).
Experience with software lifecycle processes in quality‑regulated or hybrid hardware/software products.
Experience supporting multiple manufacturing sites or global operations.
Background working with CMOs and external suppliers.
Strong analytical and problem‑solving skills with demonstrated root‑cause expertise.
Excellent verbal and written communication skills across multiple levels of the organization.
Strong project management skills; able to manage multiple priorities in a fast‑paced environment.
Ability to influence cross‑functional partners and drive alignment across diverse teams.
Hands‑on, collaborative mindset with willingness to travel and engage onsite.
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?
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 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
.
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$124,700.00 - $205,800.00 USD AnnualExplore related positions you might be interested in
We'll notify you when matching roles are posted.
Interviewed at Becton Dickinson?
Help others prepare — share your experience anonymously.
MEDICAL DEVICES
Upgrade to Pro to access all 5 linked drug products and competitive intelligence and other premium pharma intelligence.
Upgrade to Pro — $25/mo