Medical Device Quality Engineer - 1st Shift

Regulatory Jobs; Lakeville (MN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health and Wellness

401k with match

Tuition Reimbursement

EAP

Professional Development

Job summary

EPTAM Precision Micro-Machining is hiring a Quality Engineer on 1st Shift in Lakeville, MN to support the QMS and ensure ISO 13485 and 21 CFR Part 820 compliance for medical device components. You will collaborate across Engineering, Quality, and Manufacturing to uphold high standards for OEM partners.

Responsibilities include maintaining documentation, leading CAPA, Change Control, and MRB activities, and executing IQ/OQ/PQ validations with precision measuring tools and inspection plans.

Qualifications

• 1+ year of QA experience or training in a manufacturing/regulated environment.
• Bachelor’s degree in STEM preferred but not required.
• Experience with ISO 13485 and 21 CFR Part 820 is desirable.

Responsibilities

• Maintain Quality Management System documentation and report quality issues and projects.
• Support CAPA, Change Control, MRB, and NC tracking.
• Coordinate QMS-related documentation and Change Control activities.
• Assist process owners and managers in quality improvement and control methods.
• Oversee customer-driven acceptance activities and inspections.
• Develop, review, and maintain inspection plans and validation protocols (IQ/OQ/PQ).
• Perform measurements with CMM and vision systems; use calipers and micrometers.

Skills

Quality Assurance

Regulatory compliance

Documentation

Communication

Education

High School diploma or GED

Bachelor’s degree in STEM

Tools

CMM

Vision systems

Calipers

Micrometers

Job description

EPTAM Precision Micro-Machining is hiring a Quality Engineer on 1st Shift in Lakeville, MN to support the QMS and ensure ISO 13485 and 21 CFR Part 820 compliance for medical device components. You will collaborate across Engineering, Quality, and Manufacturing to uphold high standards for OEM partners.

Responsibilities include maintaining documentation, leading CAPA, Change Control, and MRB activities, and executing IQ/OQ/PQ validations with precision measuring tools and inspection plans.