Manufacturing Quality Engineer

EPTAM Precision Metals is seeking a Quality Engineer- 1st Shift to join our team in Colorado Springs, CO.

We are seeking a Quality Engineer who has experience in monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR part 820. This position provides focused, Quality Engineering support via communication to department managers of QMS to include complaint, CAPA, risk management, supplier quality and document control processes.

Join us as we manufacture medical implants and internal fixation devices that bring positive outcomes for our customers and life-impacting experiences for their patients.

EPTAM Precision Metals, nestled in Colorado Springs, Colorado, operates from a high-tech, 70,000-square-foot facility, specializing in medical implants and instrumentation. Our facility, accredited with FDA-registration and ISO 13485 certification, features essential resources including a Class 7 clean room, automated inspection, a validated supply chain, and a dedicated R&D cell.

At EPTAM, precision is paramount. We provide 3-, 4-, and 5-axis CNC milling, gun drilling, water jet cutting, Swiss and Super-Swiss machining, and EDM machining. With our extraordinary team and processes, we deliver unparalleled services to our employees, customers, and the end-users of our medical devices.

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 and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world.

POSITION SUMMARY: The Quality Engineer is primarily responsible 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 essential functions.

• Ensure Quality Management System documentation and reporting of all Quality-related issues and projects are maintained.
• Identify and support the 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 Systems.
• 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 the 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.

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 them 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) is preferred, but not required.

EXPERIENCE: 3+ years of relevant quality assurance experience or training or equivalent combinations of education and experience accepted or demonstrated ability to execute the Essential Functions for this position. Internships and PT experience are 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.

ADP1151

2XB-240418-141