Job DescriptionReporting 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
- Lead Project Quality: 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
Salary Range for Franklin Lakes, NJ: $ 110,200.00 - 176,400.00 USD Annual
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsWork ShiftSalary Range Information$110,200.00 - $176,400.00 USD Annual
