What are the responsibilities and job description for the Document Control Specialist position at EPTAM Plastics?
EPTAM Precision Micro-Machining is looking for a Document Control Specialist – 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. 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.
EPTAM Micro-Machining in Lakeville Minnesota 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.
EPTAM Micro-Machining is 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.
Benefits Include:
- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Reimbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
SHIFT DETAILS:
1st Shift Monday to Friday 7:00 am - 3:30 pm
POSITION SUMMARY: The Document Control Specialist is responsible primarily for the following:
ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Manage, develop, update, review, approve, and maintain all controlled documents, including processing and recording revisions.
- Assist in the maintenance of document templates and guidelines.
- Collaborate with teams to gather and consolidate data for document processing.
- Identify improvements to the Document System; communicate solutions/strategies
- Adhere to Company policies as defined in the Employee Handbook
- Conduct regular audits of document management practices to ensure compliance.
- Observe and assist with data entry of methods on first time projects.
- Engineering Change Order (ECO) processing.
- Update inspection plans (IP)
- Equipment Qualification Plans (EQP)
- Assist with observations of employees performing documented and hands-on processes and provide feedback (including development of Work Instructions)
- Represent the company during customer, internal, and ISO audits, as well as FDA inspections.
EDUCATION AND EXPERIENCE:
- EDUCATION: Associate’s degree in a related field of Business Administration, Information Technology, or Technical Writing preferred. High school diploma or general education degree (GED).
- EXPERIENCE: 1 year of related administrative experience and/or training, or an equivalent combination of education and experience. Internships and PT experience acceptable. Experience within a manufacturing environment is preferred but not required.
ADP1263
OHR-250206-265
1st Shift Monday to Friday 7:00 am - 3:30 pm