Quality Assurance Engineer I

CoorsTek; Grand Junction (CO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid Time Off

Medical, Dental, Vision Benefits

Company-Matched 401K

Wellness Reimbursement Program

Performance-Based Bonuses

Job summary

A leading engineering firm in Grand Junction seeks a Quality Assurance Engineer to design and optimize quality control methods for medical devices. Candidates should have at least 3 years of experience in the medical device industry, with a focus on regulatory submissions and quality standards. The role offers competitive benefits including paid time off, health insurance, and bonus programs. Join a team committed to making a measurable impact on technology and community.

Qualifications

• Experience in quality or regulatory product submissions.
• Demonstrated ability to manage qualifying medical devices.
• Working knowledge of FDA and ISO regulated standards.

Responsibilities

• Design and install quality assurance systems.
• Evaluate and improve quality control methods.
• Communicate complex technical information effectively.

Skills

Quality assurance methods

Regulatory product submissions

Statistical techniques

Communication skills

CMM/fixture interface

Education

Minimum 3 years’ experience in medical device industry

Job description

Key Responsibilities Design, install, and continually evaluate quality assurance and control methods and systems. What Makes This Role Exciting 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** **Experience** Minimum 3 years’ relevant experience within the medical device industry with a focus on quality or regulatory product submissions; manufacturing experience preferred. preferred; ceramics or advanced materials experience a plus but not 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. CMM/fixture interface experience a plus, but not required.Making the world measurably better...one person at a time.CoorsTek products and components touch people’s lives in unexpected, awe-inspiring ways. Though most people may not realize it, CoorsTek components enable technological solutions across virtually every industry—from simple items like beverage dispensers and light switches to high-tech items like cell phones and satellites. Chances are, you are using a CoorsTek-enabled technology every day without even knowing it!We create these amazing solutions by leveraging our expertise in materials science, deploying best-in-class R&D capabilities, and by creating efficient, safe work environments. Most importantly, we employ dedicated, hardworking, and creative individuals. The key component to our success is our people.**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.****Benefits:**• Paid Time Off• Medical, Dental, Vision Benefits• Company-Matched 401K **(USA only)**• Company-Matched Pension Plan **(CANADA only)**• HSA (Health Savings Account) with Company Contribution• Wellness Reimbursement Program **(USA only)**• Voluntary Benefits (Pet Insurance, Legal Insurance, Accident Insurance, Critical Illness Insurance & more) **(USA only)**• Safety Programs (reimbursement for safety shoes and company provided safety glasses)• Performance-Based Bonuses for all Employees• Employee Recognition Programs• Mentorship Program• Community & Volunteer Events & MORE!