Senior Quality Engineer
$110.2k - $176.4kBecton Dickinson & Co
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. 21CFR Part820, ISO13485, ISO14971, MDSAP, EUMDR/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. Additional Requirements Remote or field‑based positions will have different workplace arrangements indicated in the job posting. Workplace Presence Minimum 4 days of in‑office presence per week. Benefits 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: BD401(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; Bereavement leaves; Military leave; Personal leave; Family and Medical Leave (FML); Jury and Witness Duty Leave Salary Range $110,200.00-$176,400.00 USD Annual EEO Statement 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. #J-18808-Ljbffr Becton Dickinson
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