Quality Engineer- 1st Shift

EPTAM Plastics•Lakeville, MN

9d•$65,000 - $72,000•Onsite

About The Position

EPTAM Precision Micro-Machining is seeking a Quality Engineer for the 1st Shift to join their team in Lakeville, MN. The role involves creating medical devices and supporting OEM partners in producing life-saving parts. EPTAM Precision Micro-Machining is a world-class manufacturer specializing in custom medical device components for original device manufacturers, with a strong reputation in implantable components across various medical sectors. They support the Robot Assisted Surgery (RAS) and Minimally Invasive Surgery (MIS) industries. The facility is FDA and ISO 13485 compliant, known for its high-quality systems and standards, fostered by a culture of quality and collaboration between Engineering, Quality, and Manufacturing Operations. EPTAM Solutions, the parent company, emphasizes the importance of their parts touching lives and fosters an employee-focused environment.

Requirements

High School diploma or general education degree (GED).
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.
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.

Nice To Haves

Bachelor’s degree with a major in a relevant technical field (STEM) preferred, but not required.
Experience within a manufacturing, medical device company or other similarly regulated manufacturing environment preferred.
Industry recognized Quality certification(s) preferred, but not required.

Responsibilities

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.
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.