Quality Engineer
Becton, Dickinson and Company (BD)
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Job summary
Becton, Dickinson and Company (BD) is seeking a Quality Engineer at its Delran, USA site to author, review and approve QMS documents. You will participate in project teams, investigate quality issues, and drive CAPAs to improve processes and meet regulatory standards.
The role requires a Bachelor's in Biomedical/Engineering or related field and 3 years in medical devices or manufacturing in a quality engineering capacity. On-site work with strong collaboration across teams is expected.
Qualifications
- Bachelor’s degree in Biomedical/Engineering or related field.
- 3 years of experience in medical devices/manufacturing in a Quality Engineering role or equivalent.
Responsibilities
- Lead validation activities and author/execute protocols for new product development and process changes.
- Provide technical and quality engineering support for manufacturing and sustaining projects.
- Investigate quality issues, initiate NCRs, and manage MRB processes; drive CAPAs.
Skills
Education
Tools
Job description
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.
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.
- 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.
- 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.
- 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
- Ability to lift approximately 25 pounds
- Ability to stand long hours on the production floor and/or QC lab.
- 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.
- 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
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- 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), 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
- 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: $83,500.00 - 133,500.00 USD Annual
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.
USA NJ - Delran
US BD 1st Shift 8am-430pm (United States of America)
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 $83,500.00 - $133,500.00 USD Annual
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