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Senior Validation Engineer
2 months ago
We are seeking a highly skilled Team Lead Validation Engineer to join our team at Triunitysoft, Inc. in San Jose, CA.
About the Role:
The successful candidate will be responsible for leading the validation team in the development and execution of test methods for Design V&V, Process Validation, and Production. This includes process and equipment qualification, validation of test methods, and execution of engineering builds, gauge R&R studies, attribute analysis studies, and other validation work.
Key Responsibilities:
- Develop and implement validation strategies for medical device manufacturing
- Lead a team of validation engineers in the development and execution of test methods
- Collaborate with cross-functional teams to ensure compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485
- Author and release new test methods and edit/redline existing methods
- Work in a regulated and/or medical device environment to define equipment requirements, draft equipment specifications, and work on change management and releasing engineering change orders
Requirements:
- 6 years of relevant experience in medical device manufacturing
- Clean room environment experience
- Experience with Test Method Validation and/or Measurement System Analysis is preferred
- Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred)
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485
- Strong organizational skills, detail oriented
- Ability to collaborate within an organization across all functional departments
- Ability to work to a deadline and handle multiple tasks simultaneously
What We Offer:
Triunitysoft, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply:
If you are a motivated and experienced validation engineer looking for a new challenge, please submit your resume and a cover letter outlining your qualifications and experience.