Quality Technician- 1st Shift
About The Position
EPTAM Precision Micro-Machining is looking for a Quality Technician – 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 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.
Requirements
- High School diploma or general education degree (GED).
- 3+ 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.
Nice To Haves
- Associate degree, vocational training, or equivalent combination of education is preferred, but not required.
- Industry recognized Quality certification(s) preferred but not required.
Responsibilities
- Performing inspections in accordance with documented procedures to ensure compliance with customer requirements and the Quality Management System (QMS).
- Supports a controlled and efficient inspection flow and contribute to continuous improvement efforts related to inspection processes, systems, and procedures.
- Adhere to all Quality Management System (QMS) requirements, documented procedures, and company policies
- Identify, document, and communicate deviations, non-conformances, and quality issues; support containment and segregation of non-conforming products
- Assist with root cause investigations, corrective actions, and continuous improvement initiatives
- Perform inspections including First Article, start-up, in-process, receiving, and final inspections in accordance with applicable procedures and standards
- Verify product conformance, including dimensions, visual characteristics, labeling, traceability, and purchased material requirements
- Execute sampling inspections and collect accurate inspection data to support SPC, trend analysis, and quality reporting
- Operate, set up, and program advanced inspection equipment (i.e., CMM, vision systems, etc.)
- Maintain calibration status awareness and support calibration activities, including verification of tool readiness prior to use
- Ensure proper handling, storage, and maintenance of inspection equipment, fixtures, and accessories
- Complete assigned tasks, special projects, and other duties as directed by management
- 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.
- 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.
- Support training of personnel on inspection methods; ensure training is documented per procedures
- Coordinate inspection priorities with the Quality Manager in alignment with production schedules
- Assist in development, revision, and implementation of inspection procedures, in-process inspection sheets, and related quality documentation
- Provide feedback to improve inspection processes, methods, and overall quality system effectiveness
- Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.
Benefits
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
