Quality Assurance Engineer I

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.
• Coincide with 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.

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.

Target Hiring Range

USD 75,000.00 - USD 91,000.00

Actual compensation is commensurate with experience, skills and education.