New · posted Nov 3
Eptam West · Medical Devices
Quality Engineer - 1st Shift
- Lakeville, MN
- On-site
- Full-time
- Associate & Specialist
The role
EPTAM Precision Micro-Machining is looking for a Quality Engineer – 1st Shift to join our team in Lakeville, MN. Join us as we create medical devices that support our OEM partners in creating life-saving parts and positive outcomes for their patients.
EPTAM Precision Micro-Machining in is a world-class manufacturer specializing in precision manufacturing of custom medical device components for original device manufacturers. We've established a strong reputation in providing custom implantable components across various medical sectors, including orthopedic, orthopedic spine, cardiovascular, vascular, endovascular, and pelvic health sectors. Our manufacturing operations support the Robot Assisted Surgery (RAS) and Minimally Invasive Surgery (MIS) industries, as OEM’s look for partners for the future of advanced interventions.
Our facility, compliant with FDA and ISO 13485 standards, is celebrated for its high-quality system and standards. Our ingrained culture of quality, combined with seamless collaboration between Engineering, Quality, and Manufacturing Operations, allows us to deliver the very best to our employees, customers, and the world.
EPTAM Solutions, our parent company with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee focused company. We excel at what we do for our customers, our employees, and the world.
What you need
- EDUCATION: High School diploma or general education degree (GED). Bachelor’s degree with a major in a relevant technical field (STEM) preferred, but not required.
- EXPERIENCE: 1+ year(s) relevant quality assurance experience or training, equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience acceptable. Experience within a manufacturing, medical device company or other similarly regulated manufacturing environment preferred.
- LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: Industry recognized Quality certification(s) preferred, but not required.
ADP1550
1st Shift
Monday through Friday 6:00am to 2:30pm
What you'll do
OTHER RESPONSIBILITIES
- Represent the company, as required, during customer, internal and ISO audits, as well as FDA inspections.
- Support communication that ensures management and employee understanding of current Good Manufacturing Practices (cGMP).
- Leverage industry practices and apply to internal systems and processes.
- Ensure quality requirement flow down of customer purchase orders for products to be manufactured.
- Identify quality system needs and convey same to Quality Manager for strategic planning and budgeting purposes.
- Implement statistical process analysis on new and existing products as needed.
- Identify, suggest, and lead changes to benefit the organization within the Quality System or Production.
- Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.
Pay and benefits
Eptam West didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Benefits Include
Professional Development/On the Job Training
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)
Where you'll work
Lakeville, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Lakeville, MNSchedule and working conditions
Days
Hours
1st Shift
Monday through Friday 6:00am to 2:30pm
POSITION SUMMARY: The Quality Engineer is primarily for the following:
- Assisting with monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR part 820 (Quality System Regulation).
- Providing focused, Quality Engineering support via communication to department managers of the Quality Management System including Complaint, CAPA, Risk Management, Supplier Quality and Document Control processes.
- Ensure Quality Management System documentation and reporting of all Quality-related issues and projects are maintained.
- Identify and support Quality Manager by executing plans and actions to achieve assigned quality goals.
- Coordinate the tracking and closure of Quality issue-related documentation and Change Control related to RMA, NC, CAPA, and MRB System.
- Support process owners and department managers/value stream leaders in methods of process improvement and process control related to RMA, NC, CAPA, and other Quality Management issues or concerns.
- Monitor customer requests and ensure successful execution of customer-driven acceptance activities.
- Develop, vet, and maintain inspection plans.
- Draft IQ, OQ, and PQ protocols, execute validations within work cell(s), and write validation reports (IQ/OQ/PQ) for equipment and processes.
- Measure components utilizing advanced measuring equipment (i.e., CMM, vision systems, etc.) and various hand gages such as calipers and micrometers.
- Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.
Equal opportunity, accessibility and legal noticesEptam West's statements, word for word
ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in Minnesota19 roles publishing pay
Associate & Specialist roles in the US185 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Minnesota (middle half) | $52,000 | $59,000 | $81,750 |
| All US (middle half) | $59,000 | $80,000 | $95,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 965 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Eptam West's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Quality systems and risk3
- GMP and compliance2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Eptam West on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 3
- Locations
By discipline
- Quality5 100%
By level
- Associate & Specialist4 80%
- Senior & Principal1 20%
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Quality Engineer - 1st Shift at Eptam West
Open until filled.