Quality Laboratory Manager - Buffalo Grove, United States - Flextronics
Description
Job Posting Start Date Job Posting End Date
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.
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.
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.-
- 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
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