Quality Engineer - Medical Devices, CAPA & Process Improvement

LAB Medical Manufacturing; Billerica (MA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Paid time off

LTD

STD

Life insurance

401K with match

Job summary

Lab Medical Manufacturing Inc. in Massachusetts is seeking a Quality Engineer to support new product development as well as sustaining existing products. You will monitor non-conformances and drive CAPA, lead MRB, and collaborate with engineering on process improvements. The role requires a BS in engineering, 5 years in medical device manufacturing, and proficiency in Minitab and MS Office; ISO 13485 internal auditor training is a plus.

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 non-conformances and corrective actions.
• Act as chairperson of the MRB process.
• Provide guidance and training for QA and manufacturing personnel.
• Manage the customer complaint and RMA processes.
• Be the primary liaison with customers on risk management (PPAP, PFMEA, Control Plans).
• Perform and/or assist in Gage R&R and IQ/OQ/PQ validation activities.
• Collaborate with engineering on new process development.
• Document and implement Engineering Change Orders.
• Create and maintain Device History Records and inspections.
• Conduct internal ISO13485 audits.
• Manage CAPA for internal and external non-conformances.

Education

Bachelor of Science in Mechanical, Manufacturing, or Biomedical Engineering

Tools

Minitab

Microsoft Office

Job description

Lab Medical Manufacturing Inc. in Massachusetts is seeking a Quality Engineer to support new product development as well as sustaining existing products. You will monitor non-conformances and drive CAPA, lead MRB, and collaborate with engineering on process improvements. The role requires a BS in engineering, 5 years in medical device manufacturing, and proficiency in Minitab and MS Office; ISO 13485 internal auditor training is a plus.