Quality Engineer
BD
Summary
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.
Job description
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
Requirements
- 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 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
Benefits
- Annual Bonus Potential
- Discretionary LTI Bonus
- 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
- 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
- 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
- Paid time off (PTO)
- 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
- 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
Company overview
BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.