Quality Engineer - Medical Devices (1st Shift)

Eptam Plastics, Inc.; Lakeville (MN); On-site; USD 73,000 - 90,000; Full time

Benefits offered by this job

Health and Wellness Benefits

Professional Development/On the Job

401k w/ Company Match

Employee Assistance Program (EAP)

Tuition Re-imbursement

Competitive Pay/Merit Increases

Clean, Friendly, Safe work Environment

Job summary

EPTAM Precision Micro-Machining in Lakeville, MN seeks a Quality Engineer for 1st shift to support ISO 13485 and 21 CFR 820 compliance. You will help maintain the QMS, drive CAPA activities, and assist with inspections and validations in a regulated medical device environment.

The role requires 4+ years of QA experience, an aptitude for process improvement, and collaboration with Engineering, Quality, and Manufacturing teams. Competitive salary and benefits are offered.

Qualifications

• 4+ years of quality assurance experience in manufacturing.
• Experience with ISO 13485 and FDA QSR/21 CFR 820 preferred.
• Bachelor’s degree in STEM preferred but not required.

Responsibilities

• Maintain and document the Quality Management System (QMS).
• Support CAPA, nonconformances, and change control processes.
• Develop inspection plans and participate in supplier quality activities.
• Assist with audits and customer quality requirements.
• Coordinate validation activities (IQ/OQ/PQ) and related reports.

Skills

Quality Assurance

QMS

CAPA

GMP

Education

High School Diploma

Bachelor's Degree in STEM (preferred)

Tools

Measurement equipment (CMM)

Validation protocols

Job description

EPTAM Precision Micro-Machining in Lakeville, MN seeks a Quality Engineer for 1st shift to support ISO 13485 and 21 CFR 820 compliance. You will help maintain the QMS, drive CAPA activities, and assist with inspections and validations in a regulated medical device environment.

The role requires 4+ years of QA experience, an aptitude for process improvement, and collaboration with Engineering, Quality, and Manufacturing teams. Competitive salary and benefits are offered.