Quality Engineer – Medical Devices, CAPA & Validation

BD; Riverside Township (NJ); On-site; USD 84,000 - 134,000; Full time

Job summary

BD in Delran, NJ is seeking a Quality Engineer to author, review, and approve QMS documents and records supporting quality objectives. You will serve as the quality representative on project teams, investigate quality issues, and drive corrective and preventive actions across manufacturing and supply chains.

The role requires a Bachelor’s degree in Biomedical/Engineering or related field and at least 3 years of experience in medical devices or a manufacturing environment.

Qualifications

• Bachelor’s Degree in Biomedical/Engineering or related field required.
• 3 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.

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 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.

Skills

Quality engineering

Communication skills

Multi-tasking

Project planning

Team collaboration

Problem solving

Education

Bachelor’s Degree in Biomedical/Engineering or related field

Tools

Minitab

MS Excel

Job description

BD in Delran, NJ is seeking a Quality Engineer to author, review, and approve QMS documents and records supporting quality objectives. You will serve as the quality representative on project teams, investigate quality issues, and drive corrective and preventive actions across manufacturing and supply chains.

The role requires a Bachelor’s degree in Biomedical/Engineering or related field and at least 3 years of experience in medical devices or a manufacturing environment.