We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do…
- FDA inspection experience as SME interface.
- Develop and track validation related metrics. (e.g. Validation Master Plan)
- 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.
- Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team
- Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program
- Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
- Interface with customers on technical/quality issues and improvement initiatives
- Responsible for managing customer audits and regulatory/compliance agency audits
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures
Here is some of what you'll need (required)…
- Bachelors of Science degree with emphasis in Engineering discipline
- 5-10 years of experience
- Must have prior experience with FDA regulations and ISO 13485 compliance and validation
- Experience in contract manufacturing or medical manufacturing environment
- Familiarity with PCBA and sub-assembly production processes.
- Experience coordinating upper management formulating and establishing company policies, operating procedures and goalsExperience interfacing with both internal and external customers
Here are a few examples of what you'll get for the great work you provide…
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices 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. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: email@example.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
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