Quality Engineer

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.

Responsibilities:

· 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 ISO13485:2016.

· Manage CAPA process for both external and internal non-conformances.

Qualifications:

• Bachelor of Science in Mechanical, Manufacturing, or Biomedical Engineering.
• 3-5 years of medical device manufacturing experience.
• ISO 13485:2016 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.

Job Type: Full-time

Pay: $80,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off

Education:

• Bachelor's (Preferred)

Experience:

• medical device manufacturing: 5 years (Preferred)

Ability to Commute:

• Billerica, MA 01821 (Preferred)

Work Location: In person