Quality Systems Engineer

EPTAM Precision Metals is looking for a Quality Systems Engineerto join our team in Colorado Springs, CO. 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.

POSITION SUMMARY: The Quality Systems Engineer is primarily responsible for the following:

• Oversee effective implementation of the Quality Management System (QMS).
• Lead and undertake audits across all areas of the business.
• Provide training and champion the Quality Management System.
• Manage CAPA and Complaints systems and reporting performance.
• Perform root cause analysis and resolve problems.
• Perform data analysis and trending and report such trends in management reviews.
• Oversee effective implementation of the Quality Management System, including any business accreditations.
• Maintain the Quality Management System and ensure contents are appropriate for business, in collaboration with the Quality Manager.
• Organize and manage the plant internal audit system and the corrective action reporting system.
• Conduct Quality Systems audits and assist in training/guidance to internal auditors.
• Assist/support Quality Manager during external Quality System audits.
• Provide training on Quality issues and awareness.
• Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
• Compile quality data and report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• 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.

SCHEDULE:

Monday-Friday 8:00am to 4:30pm

EDUCATION AND EXPERIENCE:

• EDUCATION: Bachelor's degree in an engineering field, or relevant technical field (STEM) preferred, but not required.
• EXPERIENCE: 3 year(s) of progressive experience in manufacturing and/or quality in an FDA, and ISO 13485 operating environment, demonstrating acumen, and understanding of QMS and Operations; equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position.
• LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: None

ADP1197

2XB-240903-187

Monday-Friday 8:00am to 4:30pm