Quality Assurance Engineer I

• 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.

Experience

• Minimum 3 years’ relevant experience within the medical device industry with a focus on quality or regulatory product submissions; manufacturing experience preferred.

• Background in medical device design, regulatory affairs, or quality management strongly preferred; ceramics or advanced materials experience a plus but not required.

• Demonstrated experience managing the technical aspects of qualifying medical devices for patient use, including recommending ISO standards, testing processes, and design controls.

Technical Skills & Competencies

• Working knowledge of medical device regulated quality or regulatory standards (FDA 21 CFR 820, ISO 13485).

• Ability to recommend and implement ISO standards, testing processes, design controls, and regulatory affairs requirements.

• In-depth knowledge of statistical techniques (SPC, DOE, capability studies); ability to identify, analyze, and define solutions for continuous improvement.

• Advanced math skills; ability to interpret and communicate technical data in mathematical or diagram form.

• Excellent communication skills; ability to read, analyze, and present complex technical information to diverse audiences.

• Effective collaborator across engineering, production, and customer-facing teams.

• CMM/fixture interface experience a plus, but not required.