Medical Device Quality Engineer - QA, CAPA & Compliance

LAB Medical Manufacturing; Billerica (MA); On-site; USD 90,000 - 110,000; Full time

Job summary

Lab Medical Manufacturing Inc. is seeking a Quality Engineer to support new product development as well as sustaining existing products. The role focuses on non-conformances, CAPA, MRB leadership, and customer risk management.

The candidate will work with manufacturing, quality control, and engineering to drive process improvements, validation activities, and change control while maintaining ISO13485 compliance across DHRs and inspections.

Qualifications

• BS in Mechanical, Manufacturing, or Biomedical Engineering.
• 5 years of medical device manufacturing experience.
• ISO 13485 Internal Auditor training is a plus.
• Proficiency in Minitab data analysis software.
• Proficiency in Microsoft Office suite.

Responsibilities

• Monitor, identify, and report on non-conformances and corrective actions to prevent recurrence.
• Act as chairperson of the MRB process and coordinate reviews.
• Provide guidance and training for manufacturing and quality control personnel on QA and process control.
• Manage customer complaints and RMAs and ensure timely closure.
• Liaise with customers on risk management activities (PPAP, PFMEA, Control Plans).
• Perform and/or assist in Gage R&R and IQ/OQ/PQ validation activities.
• Collaborate with Engineering on development of new processes.
• Document and implement Engineering Change Orders as required.
• Create and maintain Device History Records and Inspection documents.
• Conduct internal audits per ISO13485 and close CAPA for internal/external non-conformances.

Skills

Quality Assurance

Risk Management

Process Improvement

Engineering Change Control

Interdepartmental Collaboration

Education

BS in Mechanical, Manufacturing, or Biomedical Engineering

Tools

Minitab

Microsoft Office

Job description

Lab Medical Manufacturing Inc. is seeking a Quality Engineer to support new product development as well as sustaining existing products. The role focuses on non-conformances, CAPA, MRB leadership, and customer risk management.

The candidate will work with manufacturing, quality control, and engineering to drive process improvements, validation activities, and change control while maintaining ISO13485 compliance across DHRs and inspections.