Quality Assurance Engineer I

CoorsTek, Inc.; Grand Junction (CO); On-site; USD 75,000 - 91,000; Full time

Job summary

CoorsTek, Inc. in Grand Junction, CO, is seeking a Quality Assurance Engineer I to join the Bioceramics Quality team. You will partner with medical device customers on regulatory and product qualification submissions, supporting expansion into new geographies and programs.

The ideal candidate has a background in medical device quality or regulatory affairs and will solve complex technical challenges at the intersection of advanced materials and patient care.

Qualifications

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

Responsibilities

• Serve as the primary quality engineering liaison for medical device customer programs, supporting regulatory and product submissions (FDA 21 CFR 820, ISO 13485).
• Partner with customers to complete qualification activities for Bioceramics as a supplier, including process flow documentation and testing.
• Design, install, and continually evaluate QA and QC methods and systems.
• Develop standards, procedures, and work instructions for quality guidance and training.

Skills

Quality engineering

Regulatory affairs

Statistical methods

Cross-functional collaboration

Education

Bachelor’s degree in a related technical field

Professional Engineer (PE) and/or ASQ CQE

Tools

CMM/Fixtures interface

Job description

It's exciting to work for a company that makes the world measurably better.

We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing.

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.

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.

CoorsTek strives to give all qualified applicants equal opportunity and to make selection decisions on job related factors. Do not provide any information on the application which will indicate your race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, pregnancy, genetic information, veteran status, or any other status protected by law or regulation.

If you like working for a company that makes a real difference in the world, you'll enjoy your career with us!