Job Posting Start Date 05-21-2024 Job Posting End Date 08-02-2024
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.
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Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Lab Manager located in Buffalo Grove, IL.
Reporting to the Sr. Director Quality, the Quality Lab Manager role is responsible for the operation and compliance of the Laboratory Services function within Quality. Laboratory Services include ISO cleanroom environmental monitoring, product bioburden monitoring, product sterilization/irradiation and bacterial endotoxin.
What a typical day looks like:
- Sustain cleanroom operational standards, ensuring compliance with ISO cleanroom standards.
- Sustain product release commitments through timely completion of product monitoring and release testing.
- Engage in External Audit/Inspection Processes (Customers', Notified Bodies, Competent Authorities, etc.) as a Sterilization and Cleanroom SME.
- Maintain the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures relating to cleanroom operations and production of sterile medical devices .
- Develop training programs for internal users in subjects related to cleanroom operations, medical device sterilization and microbiological-related product testing.
- Create audit reports that identify any Non-Conformance or Opportunities for Improvement found during the audit process.
- Follow up on internal and external corrective actions to ensure timely implementation and validate their effectiveness.
- Bachelor's degree in Engineering, Microbiology, Chemistry or related field of study.
- 6+ years of experience developing, implementing and maintaining cleanroom operation and product sterilization.
- Demonstrates advanced/thorough knowledge of Regulatory and Quality Audits Process Regulations and Quality Standards
- Management or Supervisory experience in a sterilization
- Must have experience in the medical device or pharmaceutical industry
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- PTO
- Tuition Reimbursement
- Employee discounts at local retailers
Job Category
Quality
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 application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).