Quality Assurance Engineer I

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Job Title

Quality Assurance Engineer I

CoorsTek is seeking a Quality Assurance Engineer I to join the Bioceramics Quality team in Grand Junction, CO. This is a key growth-enabling role responsible for partnering with medical device customers on regulatory and product qualification submissions, supporting expansion into new geographies and customer programs. The ideal candidate brings a background in medical device quality or regulatory affairs and is passionate about solving complex technical challenges at the intersection of advanced materials and patient care.

Key Responsibilities 

• Serve as the primary quality engineering liaison for internal and external medical device customer programs, supporting regulatory and product technical submissions (FDA 21 CFR 820, ISO 13485). 

• Partner with customers to complete qualification activities for CoorsTek Bioceramics as a supplier, including process flow documentation, risk documentation, measurement system comparisons, and material property testing. 

• Design, install, and continually evaluate quality assurance and control methods and systems. 

• Develop standards, procedures, and work instructions to provide quality guidance and facilitate training. 

• Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct and support internal and external audits. 

• Develop sampling plans and statistical methods for manufacturing and inspection; determine control points and charting methods. 

• Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions. 

• Develop, generate, and analyze reports and returned products to identify trends and facilitate corrective action and quality improvements. 

• Interface with engineering and production teams to design fixtures and processes that ensure measurement system effectiveness. 

 

What Makes This Role Exciting 

• Key growth enabler for the Bioceramics business — you’ll partner directly with new customers to expand geographic footprint and support increasing production demand. 

• Forefront of new product and material development — solving novel technical challenges in advanced materials used in medical applications. 

• High visibility role with direct impact on CoorsTek’s ability to serve medical device OEMs and grow its position as a critical supplier. 

 

Requirements 

Education 

• Bachelor’s degree in a related technical field; Professional Engineer (PE) and/or ASQ Certified Quality Engineer (CQE) a plus