Job Details
Location: Salt Lake City, Utah, United States
Salary: Not specified
Company: ApnaWorker
We are seeking an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities.
Key Requirements:
- Prior Medical Device industry experience (Mandatory).
- Strong knowledge of ISO 13485 and ISO 14971.
- Hands-on experience with IQ, OQ, and PQ validation activities.
- Validation planning, execution, and documentation expertise.
- Equipment, process, and product transfer validation experience.
Key Responsibilities:
- Plan, lead, and coordinate validation activities.
- Execute equipment, process, and product transfer validations.
- Author and review validation protocols, reports, and related documentation.
- Ensure compliance with regulatory and quality standards.
Ideal candidates will have a proven track record in medical device validation, regulatory compliance, and successful project execution within a regulated environment.
- Bachelor's Degree in Mechanical Engineering.