Join BD as a Quality Engineer at our Delran, USA plant. This full-time role requires a minimum of 4 days of in-office presence per week on the 1st shift (8am-4:30pm). The position offers a competitive annual salary ranging from $83,500.00 to $133,500.00 USD, alongside comprehensive benefits. You will support quality objectives by managing QMS documents, leading validation activities, and driving continuous improvement in a dynamic medical technology environment.
Requirements
Education: Bachelor's Degree in Biomedical/Engineering or a related field is required.
Experience: 3 years of experience in medical devices and/or manufacturing in a Quality Engineering role or equivalent.
Technical Skills: Applied knowledge of FDA QSR and ISO13485, and proficiency with Minitab and MS Excel.
Preferred Qualifications: American Society for Quality Certified Quality Engineer (ASQ CQE), ASQ CQA, Six Sigma Green/Black Belt Certification, and experience with textiles are preferred.
Skills & Responsibilities
Quality Engineering and Validation: Lead validation activities, authoring and executing protocols for new product development, process improvements, and equipment changes to ensure regulatory compliance.
Nonconformance and CAPA Management: Investigate quality issues, initiate nonconformance reports (NCRs), manage MRB processes, and execute corrective and preventive actions.
Documentation and Audits: Develop quality documentation, review inspection and Lot History Records, and participate in internal and external audits.
Statistical and Root Cause Analysis: Design and conduct quality engineering studies using Minitab and MS Excel to identify root causes and improve processes, tooling, and product design.
Potential transition routes: People from manufacturing engineering or regulatory compliance roles may bring strong foundational quality skills, alongside meeting the required biomedical engineering degree and medical device experience.
Job description
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.
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.
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
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: $83,500.00 - 133,500.00 USD Annual
Why Join Us?
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.
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.
Required Skills
Optional Skills
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Primary Work Location
USA NJ - Delran
Additional Locations
Work Shift
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.
