Overview
Quality Engineer Jobs in Fort Collins, CO at PRECISION MACHINED PRODUCTS
Key Responsibilities:
Lead and mentor the Validation Technical Support Team, ensuring compliance with company and industry standards.
Review and approve sterility assurance validation protocols, including: Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), Routine cycle requalifications
Oversee validation processing for medical device manufacturers, including process cycle development, equipment setup, and direct collaboration with customers.
Assign and manage validation activities within the team, ensuring timely and efficient execution.
Conduct quality trend analysis and validation performance reporting at least annually.
Qualifications & Experience:
Bachelor’s degree (STEM-related field preferred).
3+ years of experience in validation, quality assurance, engineering, or a related field.
Expertise in ISO 11135 (EO Sterilization of Healthcare Products), ISO 13485 (International Quality Systems), and CFR 820 (FDA Quality System Regulations).
Strong problem-solving and leadership skills with a detail-oriented mindset.
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Title: Quality Engineer
Company: PRECISION MACHINED PRODUCTS
Location: Fort Collins, CO
