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 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.

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)

SHIFT DETAILS:

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.

ESSENTIAL FUNCTIONS:

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.

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.

EDUCATION AND EXPERIENCE:

• 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.