Job Title: Senior Supplier Quality Engineer – Medical Devices
Location: Lakewood, CO (Hybrid: 2-3 days onsite)
Salary: $107,000 - $133,800 + 7% Bonus

Position Overview:
Join our team as a Senior Supplier Quality Engineer in the medical device industry! This key role involves managing supplier quality programs, conducting audits, resolving issues, and ensuring compliance with ISO 13485 and FDA QSR. You will drive continuous improvement, support supplier development, and collaborate across teams to ensure the consistent delivery of high-quality components.

Responsibilities:

Develop and implement supplier quality programs compliant with industry regulations. Conduct audits and assessments to ensure supplier quality systems meet standards. Resolve quality issues and implement CAPA (Corrective and Preventive Actions). Support supplier selection, qualification, and ongoing management. Collaborate with cross-functional teams in new product development and lifecycle management. Monitor supplier performance and present improvements.

Qualifications:

Bachelor’s degree in Engineering or a related field (advanced degree preferred). 6+ years in Supplier Quality Engineering within the medical device industry. Strong knowledge of FDA, ISO 13485, and ISO 9001 standards. Experience with supplier audits and root cause analysis. Willingness to travel domestically and internationally.

Why Join Us?

Competitive salary + 7% bonus. Flexible hybrid work schedule. Comprehensive benefits including health, dental, vision, 401(k) matching, and more.

Keywords: Supplier Quality Engineer, Medical Device, ISO 13485, FDA QSR, CAPA, Supplier Development, FDA Compliance, Audits, Risk Management, Cross-Functional Collaboration, Root Cause Analysis.

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.