Quality Engineer

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 Med Tech 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.

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 ISO
  13485.
• 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,…