Quality Engineer- 1st Shift

EPTAM Plastics•Lakeville, MN

9d•$73,000 - $90,000•Onsite

About The Position

EPTAM Precision Micro-Machining is hiring a Quality Engineer for its Lakeville, Minnesota facility. The company manufactures custom precision medical device components for original device manufacturers, including implantable components for orthopedic, cardiovascular, vascular, endovascular, and pelvic health applications, and supports robot-assisted and minimally invasive surgery industries. The facility operates under FDA and ISO 13485 standards. The Quality Engineer assists in monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR Part 820. The role provides Quality Engineering support to department managers and process owners for complaint handling, CAPA, risk management, supplier quality, document control, and related quality processes. The position is on the first shift, Monday through Friday, from 6:00 a.m. to 2:30 p.m.

Requirements

High school diploma or GED.
At least 4 years of relevant quality assurance experience or training, or an equivalent combination of education and experience; demonstrated ability to perform the essential functions is also acceptable.
Ability to perform the listed essential functions, including quality system support, validation activities, and component measurement.
Ability to relate professionally to coworkers and peers and respond appropriately to supervisor feedback.

Nice To Haves

Bachelor’s degree in a relevant technical or STEM field.
Experience in manufacturing, a medical device company, or another similarly regulated manufacturing environment.
Industry-recognized Quality certification(s).
Internship and part-time experience are acceptable.

Responsibilities

Maintain QMS documentation and reporting for quality issues and projects.
Support the Quality Manager in executing plans and actions to achieve assigned quality goals.
Coordinate tracking and closure of quality issue documentation and change control related to RMA, NC, CAPA, and the MRB system.
Support process owners and department managers or value stream leaders with process improvement and process control related to RMA, NC, CAPA, and other quality matters.
Monitor customer requests and ensure customer-driven acceptance activities are successfully completed.
Develop, vet, and maintain inspection plans.
Draft IQ, OQ, and PQ protocols; execute validations within work cells; and prepare validation reports for equipment and processes.
Measure components using advanced measuring equipment, including CMMs and vision systems, as well as hand gauges such as calipers and micrometers.
Represent the company, as required, during customer, internal, and ISO audits and FDA inspections.
Support communication that promotes management and employee understanding of current Good Manufacturing Practices (cGMP).
Apply industry practices to internal systems and processes.
Ensure customer purchase order quality requirements are flowed down for products to be manufactured.
Identify quality system needs and communicate them to the Quality Manager for strategic planning and budgeting.
Perform 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.
Protect sensitive data handled by systems under the employee's control.
Work professionally with coworkers and peers and respond appropriately to supervisor feedback.