Senior Quality Engineer

Job Description

• Reporting directly to the Associate Director of Quality, you'll be at the heart of our product development journey, applying your Quality Engineering expertise to both cutting-edge new products and essential product maintenance initiatives. This is your opportunity to make a real impact on patient safety and product excellence throughout the entire product lifecycle. Responsibilities
• Drive Quality Excellence Apply advanced technical principles, quality sciences, and proven methodologies to ensure our medical devices exceed industry standards and regulatory expectations Solve Complex Challenges Leverage your proven problem-solving skills to tackle quality issues head-on, creating measurable improvements to BD's processes and procedures that enhance efficiency and effectiveness
• Champion Regulatory Compliance
• Ensure every design control and production/process control project meets all applicable local and international regulatory requirements, plus Corporate and Unit standards
• Collaborate Cross-Functionally Serve as the Quality representative on dynamic new product development and sustaining engineering teams, bringing your expertise to multidisciplinary projects Exercise Approval Authority Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specs, test methods, and critical documentation
• Develop Auditing Skills Participate in supplier and internal quality system audits as an Auditor-in-training, evaluating the effectiveness of our Quality System and good manufacturing practices
• Ensure quality conduct across projects—from design through data interpretation and report generation—for both your work and that of junior team members Shape Our Future
• Contribute to specific programs and projects that advance our quality capabilities, and prepare/revise policies and procedures that guide our organization Own the Journey
• Manage projects and tasks from product inception through launch and ongoing maintenance, ensuring products consistently meet quality standards at every stage

Required Qualifications

• Bachelor's degree in Engineering and 5 years relevant experience OR Master's degree in Engineering and 3 years relevant experience.
• Knowledge and Skills Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers. Can independently determine and develop approach to solutions. Able to provide guidance and work direction to lower level project developers. Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable. Must have knowledge/specialization in one or more of the following areas Acceptance sampling theory and application Statistical process control methods and application Measurement system/test method knowledge and analysis Quality planning Failure analysis investigation
• Design of Experiments Process mapping and value stream analysis Hypothesis testing Descriptive statistics Process capability analysis Basic quality tools Pareto, box plots, histograms, scatter diagrams, etc. Risk Management Supplier quality management Auditing
• Design/development tools Process validation Software validation 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. At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:  Annual Bonus Potential Discretionary LTI Bonus   Health and Well-being Benefits Medical coverage  Health Savings Accounts  Flexible Spending Accounts  Dental coverage  Vision coverage  Hospital Care Insurance  Critical Illness Insurance  Accidental Injury Insurance  Life and AD&D insurance  Short-term disability coverage  Long-term disability insurance  Long-term care with life insurance  Other Well-being Resources Anxiety management program  Wellness incentives  Sleep improvement program  Diabetes management program  Virtual physical therapy  Emotional/mental health support programs  Weight management programs  Gastrointestinal health program  Substance use management program  Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit  Retirement and Financial Well-being BD 401(k) Plan  BD Deferred Compensation and Restoration Plan  529 College Savings Plan  Financial counseling  Baxter Credit Union (BCU)  Daily Pay  College financial aid and application guidance  Life Balance Programs Paid time off (PTO), including all required State leaves  Educational assistance/tuition reimbursement  MetLife Legal Plan  Group auto and home insurance  Pet insurance  Commuter benefits  Discounts on products and services  Academic Achievement Scholarship  Service Recognition Awards  Employer matching donation  Workplace accommodations  Other Life Balance Programs Adoption assistance  Backup day care and eldercare
• Support for neurodivergent adults, children, and caregivers  Caregiving assistance for elderly and special needs individuals  Employee Assistance Program (EAP)  Paid Parental Leave
• Support for fertility, birthing, postpartum, and age-related hormonal changes  Leave Programs Bereavement leaves  Military leave  Personal leave  Family and Medical Leave (FML)  Jury and Witness Duty Leave  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. Salary Range for Franklin Lakes, NJ: $ 110,200.00 - 176,400.00 USD Annual ​ 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 . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.

We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You ." Our salary or hourly rate ranges reward associates fairly and competitively.

We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully.

The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information $110,200.00 - $176,400.00 USD Annual