QA Engineer I: Medical Devices & Regulatory Submissions

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

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.