Quality Engineer

Regulatory Jobs; Delran Township (NJ); On-site; USD 84,000 - 134,000; Full time

Job summary

BD in Delran, NJ, USA is seeking a Quality Engineer to author, review, and approve QMS documents, support quality objectives, and participate in audits. The role involves investigation of nonconformances, CAPAs, and working with suppliers.

The ideal candidate holds a Bachelor's in Biomedical/Engineering, has 3 years in medical devices, and strong knowledge of FDA QSR and ISO13485, with skills in Minitab and MS Excel and good communication.

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 understanding of quality and manufacturing.
• 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.

Responsibilities

• Lead validation activities and execute protocols for new product development.
• Provide technical and quality engineering support for manufacturing projects.
• Design and conduct quality studies to identify root causes and drive improvements.
• Lead investigations into quality issues, initiate nonconformance reports (NCRs), and manage MRB processes.
• Develop and maintain quality documentation, including inspection plans and QC procedures.
• Review and approve inspection records and environmental monitoring data.
• Review Lot History Records for accuracy and regulatory compliance.
• Investigate customer complaints and support CAPAs.
• Coordinate calibration of measuring equipment.
• Participate in internal and external audits and regulatory inspections.

Skills

Quality knowledge

Product development

Minitab Excel

FDA QSR ISO13485

Communication

Multitasking

Project planning

Team motivation

Education

Bachelor's in Biomedical Engineering

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.

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

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.

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.

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.

Salary Range Information

$83,500.00 - $133,500.00 USD Annual