Quality Engineer

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 an ISO 13485 registered company and has been manufacturing machined and finished assembly products for the medical industry for over 40 years.

Summary of Position:

Lab Medical Manufacturing Inc. is seeking a Quality Engineer. The candidate will support new product development as well as sustaining existing products.

The candidate will be responsible for:

• Monitor, identify, and report on non-conformances as well as corrective actions and process improvements implemented to eliminate recurrence.
• Act as chairperson of the MRB process
• Provide guidance and/or training for manufacturing and quality control personnel to enhance Quality Assurance, process control and improvement.
• Manage the customer complaint and RMA processes.
• Be the primary liaison with customers regarding risk management activities (PPAP programs, PFMEA’s, Control Plans, etc.)
• Perform and/or assist in Gage R&R and validation activities such as IQ/OQ/PQ.
• Work with engineering on the development of new processes.
• Document and implement Engineering Change Orders as required.
• Device History Record and Inspection creation and maintenance.
• Conduct and document internal audits per ISO13485
• Manage CAPA process for both external and internal non-conformances.

Qualifications:

• Bachelor of Science 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.

Lab Medical Manufacturing Inc. offers a team-oriented and excellent work environment. Our employees enjoy competitive wages, and a comprehensive benefit package including medical, dental, paid time off, LTD, STD, Life insurance and 401K with match.