What are the responsibilities and job description for the Senior Validation Engineer position at Flex?
At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives.
Job Summary
Job summary:
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Sr. Validation Engineer located in Buffalo Grove, IL
Reporting to the Quality Manager, Valitdation, the Sr. Validation Engineer role involves providing validation training and consultation services on validation policies and practices.
What a typical day looks like:
- Develop and track validation related metrics.
- Provide validation training and consultation services on validation policies and practices.
- Work closely with engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes
- Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.
- Provide risk management training and facilitation for FMEA and control plan development sessions.
- Review, analyze, and provide recommendations for verification and validation test data. (including the ability to interpreted results from Test Method Validation like Gage R&R, process capability, etc.)
- Provide guidance on resolving deviations and ECO associated with verification and validation activities.
- Evaluate validation reports to ensure compliance with ISO and FDA regulation requirements.
- Provide ISO 13485 and FDA regulation guidance (specifically CFR 820).
- Verify the validation activities as a dedicated subject matter expert to ensure the validation processes fully comply with ISO and FDA regulations requirements.
- Support process and quality engineering teams for non-conformance analysis and disposition.
- Interface with customers on technical/quality issues and improvement initiatives.
The experience we're looking to add to our team:
- Industry experience with medical devices or pharmaceutical
- 3 years of experience working as a Validation engineer.
- Experience with Validation for Automation
- Bachelors in Mechanical Engineering or Industrial Engineering or related
What you'll receive for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- PTO
- Tuition Reimbursement
- Employee discounts at local retailers
HL45
Job Category
Design, Process & Technology Engineering
Is Sponsorship Available?
No
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing: accessibility@flex.com.
