Quality Engineer: Medical Devices, 1st Shift

Eptam Plastics, Inc.; Lakeville (MN); On-site; USD 65,000 - 72,000; Full time

Benefits offered by this job

Professional development/on the job

Health and wellness benefits

Safe work environment

Tuition reimbursement

401k w/ company match

Employee assistance program (EAP)

Job summary

EPTAM Precision Micro-Machining, Lakeville, MN, is seeking a Quality Engineer for 1st shift to monitor and maintain the QMS and support CAPA, NC, and MRB processes. This role requires coordinating quality activities across departments to ensure compliance with ISO 13485 and 21 CFR Part 820.

The ideal candidate will have a STEM background and at least 1 year in medical device quality assurance, with opportunities to participate in audits, inspections, and continuous improvement initiatives in a

Qualifications

• Experience with ISO 13485 and FDA QSR (21 CFR part 820).
• 1+ year in quality assurance in manufacturing or medical device.
• Bachelor’s degree in STEM preferred, but not required.

Responsibilities

• Maintain QMS documentation and reporting of quality issues and projects.
• Coordinate CAPA, NC, and MRB activities and Change Control efforts.
• Support audits and customer inspections and ensure regulatory compliance.

Skills

Quality management

CAPA

Process improvement

Documentation control

Regulatory compliance

Team collaboration

Education

Bachelor’s degree in STEM

Tools

CMM

Vision systems

Gages & micrometers

IQ/OQ/PQ protocols

Job description

EPTAM Precision Micro-Machining, Lakeville, MN, is seeking a Quality Engineer for 1st shift to monitor and maintain the QMS and support CAPA, NC, and MRB processes. This role requires coordinating quality activities across departments to ensure compliance with ISO 13485 and 21 CFR Part 820.

The ideal candidate will have a STEM background and at least 1 year in medical device quality assurance, with opportunities to participate in audits, inspections, and continuous improvement initiatives in a