Quality Engineer

&#xa;&#xa; We are the people who give possibilities purpose 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. &#xa;&#xa; Job Description This position is responsible for authoring, reviewing and approving QMS documents and records, as required, to support BD Delran plant quality objectives. This position will act as the quality representative regarding quality interests and concerns on project teams as well as getting involved in a variety of projects which may include, resolving quality problems, improving areas of high quality costs, assisting suppliers and subcontractors in meeting BD Delran’s needs. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs. Responsibilities: Lead validation activities, including authoring and executing protocols to support new product development, process improvements, equipment changes, and test method validations. Provide technical and quality engineering support for ongoing manufacturing and sustaining projects. Design and Conduct quality engineering studies to identify root causes of nonconformances and drive improvements in processes, tooling, and product design. Lead investigations into quality issues, initiate nonconformance reports (NCRs), and manage the review and disposition of nonconforming materials through Material Review Board (MRB) processes. Develop and maintain quality documentation, including inspection plans, test methods, quality standards, and QC inspection procedures. Review and approve incoming, in-process, and final inspection records, as well as environmental monitoring data, to ensure compliance with quality requirements. Perform thorough reviews of Lot History Records (LHRs) to verify accuracy, completeness, and adherence to regulatory and quality standards. Review and approve customer specifications and product requirements to ensure alignment with quality expectations. Investigate customer complaints, determine root causes, and support corrective and preventive actions. Coordinate and perform calibration activities for measuring and monitoring equipment to maintain compliance and accuracy. Participate in internal and external audits, regulatory inspections, and quality system assessments, supporting ongoing compliance and continuous improvement initiatives. Required Qualifications: Bachelor’s Degree in Biomedical/ Engineering or related field. 3 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent. Knowledge and Skills: Knowledge and understanding of quality and manufacturing. Knowledge of product development objectives and strategies. Experience with statistical software such as Minitab and MS Excel. Applied knowledge of FDA QSR and ISO13485. Good oral and written communication skills. Demonstrated ability to multi-task. Good project planning skills and ability to meet internal/external customer needs. Ability to work with and motivate people. Preferred Qualifications: American Society of Quality Certified Quality Engineer (ASQ CQE) ISO-13485:2003 Audit training and/or American Society of Quality Certified Quality Auditor (ASQ CQA) Six Sigma Green/Black Belt Certification or similar Software qualification Experience with textiles Physical Demands: Ability to lift approximately 25 pounds Ability to stand long hours on the production floor and/or QC lab. Work Environment: Laboratory Production Environment Warehouse 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. 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 <span style="colo