Quality Engineer - Medical Devices | ISO 13485 & CAPA (1st Shift)

Regulatory Jobs; Lakeville (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Professional Development/On the Job培训

Health and Wellness Benefits

Clean, Friendly, Safe work Environment

Recognition and Rewards Program

Tuition Re-imbursement

Competitive Pay/Merit Increases

401k w/ Company Match

Employee Assistance Program (EAP)

Job summary

EPTAM Precision Micro-Machining in Lakeville, MN is seeking a Quality Engineer (1st Shift) to support the Quality Management System and ensure compliance with medical device regulations. The role focuses on CAPA, supplier quality, and control of documentation within a collaborative engineering and manufacturing environment.

You will develop inspection plans, draft IQ/OQ/PQ protocols, execute validations, and use precision measuring tools to verify components, supporting continuous improvement

Qualifications

• ISO 13485 and 21 CFR Part 820 compliance experience.
• 4+ years of quality assurance experience in manufacturing/medical devices.
• Strong documentation, change control, CAPA, and supplier quality experience.

Responsibilities

• Maintain and document the Quality Management System to ensure ISO 13485 and 21 CFR Part 820 compliance.
• Provide quality engineering support across CAPA, complaint handling, risk management, and document control.
• Coordinate tracking and closure of quality issues, NC, CAPA, MRB, and change control.
• Support process owners in methods of process improvement and control for QMS.
• Monitor customer requests and lead customer-driven acceptance activities.
• Develop and maintain inspection plans; draft IQ/OQ/PQ protocols and validation reports.
• Measure components with CMM, vision systems, calipers, micrometers.

Skills

Quality systems knowledge

QMS documentation

CAPA handling

Education

High School Diploma or GED

Bachelor’s degree in STEM (preferred)

Tools

CMM

Vision systems

Calipers

Micrometers

Job description

EPTAM Precision Micro-Machining in Lakeville, MN is seeking a Quality Engineer (1st Shift) to support the Quality Management System and ensure compliance with medical device regulations. The role focuses on CAPA, supplier quality, and control of documentation within a collaborative engineering and manufacturing environment.

You will develop inspection plans, draft IQ/OQ/PQ protocols, execute validations, and use precision measuring tools to verify components, supporting continuous improvement