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Quality Systems Manager

4 months ago

Buffalo Grove, United States Flextronics Full time

Job Posting Start Date 05-21-2024 Job Posting End Date 07-22-2024Flex 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. Job SummaryTo support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Systems Manager located in Buffalo Grove, IL.Reporting to the Sr. Director, Quality, the Quality Systems Manager role has responsibility for Regulatory and Quality Systems Internal Audits. Help the Quality Compliance team and site organization to conform and comply with regulations, internal policies, directives, and procedures in order to achieve and exceed the quality goals expected by the customer and the organization.What a typical day looks like:

  • Manage the site's Quality Compliance team to assure the conformance of all organization's regulatory and quality systems requirements.
  • Perform internal audits and/or review results from Quality Compliance team to identify trends and opportunities for improvement. Verify compliance and conformance to all regulatory and quality systems requirements, including both Customer and Flex mandated.
  • Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.).
  • Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization.
  • Develop training programs for internal users in subjects related to Regulations or Quality Systems.
  • Participate as a key member for all external audits activities and maintain records as required.
  • Follow up on internal and external corrective actions to ensure timely implementation and validate their effectiveness.
The experience we're looking to add to our team:
  • Typically requires a bachelor's degree in Engineering/related field or equivalent experience and training.
  • Typically requires a minimum of 8 years of experience developing, implementing and maintaining quality systems.
  • Must have experience in medical device or pharmaceutical industry
  • Demonstrates advanced/thorough knowledge of Regulatory and Quality Audits Process Regulations and Quality Standards (ISO9001, TL9000, ISO/TS16949, AS9100, ISO13485, ESD20.20, etc.), Internal Quality Systems Manuals and Level 1 Procedures Manufacturing Processes, Regulatory Agencies.
  • Must have knowledge of relevant regulatory standards and applicable regulations.
  • Demonstrates expert functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills.
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
HL45Job Category Quality
Is Sponsorship Available?
NoFlex 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).