MedTech Quality Engineer - CAPA, Audits & QMS Expert

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

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.