Quality Manager

Job Description

EPTAM Precision Metals is looking for a Quality Manager to 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.

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

POSITION SUMMARY: The Quality Manager plays a critical role in ensuring the safety, efficacy, and reliability of the company’s products while developing the Quality Engineering team members and fostering a team cohesive culture of compliance within EPTAM Metals. This position is on-site in our Colorado Springs, CO facility. The Quality Manager is primarily responsible for the following:

• Leading and developing the local Quality and Manufacturing personnel.
• Ensuring the company’s products meet the highest quality standards, customer requirements, and comply with all relevant regulations and industry standards.
• Provide leadership in the development, implementation, communication and maintenance of the facility Quality Management System policies and procedures.
• Achieve and maintain a high degree of joint ownership of quality and compliance strategies with all the major operational stakeholders in the organization
• Address Quality and associated regulatory requirements in an effective, timely and responsible manner.
• In Conjunction with the General Manager and the Quality Manager, accountable to develop, implement, and manage the Quality Management, work with the site leadership team to develop annual strategic deployment plans and lead key business initiatives to improve our customer offerings.
• This role will also join a team of like individuals across various plants to gain enterprise perspective, share leading practices, and drive standardization.
  
  

Additional details on the jobs roles and responsibilities will be shared during the interview process

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or related field
• 5+ years of experience in quality engineering for medical devices
• Strong understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices, including a working knowledge of 21 CFR 820, EUMDR, ISO 13485:2016, ISO 14971:2019 and IEC 62366-1:2015
• CQE Certification preferred
• Minitab experience preferred.
• Certified ISO 13485 auditor preferred
• Six Sigma/Lean Certification preferred
• Experience with Quality Management Systems and Quality System Audits.
• LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: Professional certifications desirable (including, but not limited to ASQ Quality Manager-CMQ/OE, Quality Engineer-CQE, Certified Quality Auditor-CQA)
  
  

ADP1172

2XB-240702-163

Company Description

EPTAM Precision is a comprehensive medical device manufacturer, with locations across the United States. Collaborating with OEM's our state-of-the-art facilities leverage cutting-edge machining centers, automation, and inspection equipment to meet the most exacting requirements. The expertise of our teams enhances your project by employing innovative manufacturing processes and effective problem-solving, ensuring exceptional results.

EPTAM specializes in fast-track job initiation and quick-turn prototyping, placing a strong focus on Design for Manufacturing (DFM) to streamline your product's journey from concept to market. Our commitment extends to a range of value-added services, encompassing mass finishing, in-house anodization and passivation, process validation, enhanced automation solutions, cleanroom assembly, and technical program management. Embracing the highest standards for your medical device and precision manufacturing requirements, EPTAM stands as a trusted source in crafting precise solutions for our industry partners.

EPTAM Precision is a comprehensive medical device manufacturer, with locations across the United States. Collaborating with OEM's our state-of-the-art facilities leverage cutting-edge machining centers, automation, and inspection equipment to meet the most exacting requirements. The expertise of our teams enhances your project by employing innovative manufacturing processes and effective problem-solving, ensuring exceptional results. EPTAM specializes in fast-track job initiation and quick-turn prototyping, placing a strong focus on Design for Manufacturing (DFM) to streamline your product's journey from concept to market. Our commitment extends to a range of value-added services, encompassing mass finishing, in-house anodization and passivation, process validation, enhanced automation solutions, cleanroom assembly, and technical program management. Embracing the highest standards for your medical device and precision manufacturing requirements, EPTAM stands as a trusted source in crafting precise solutions for our industry partners.