CAPA Quality Manager Job Listing at Flex in Austin, TX (Job ID WD183947)

Description

Job Posting Start Date 06-13-2024 Job Posting End Date 08-26-2024Flex 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 Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a CAPA Quality Manager located in Austin, TX.

Reporting to the Director of Quality  the CAPA Quality Manager role will be responsible for a team of medical device Quality professionals performing Quality Systems functions.    These can include Internal Audits, CAPA, Change Control, Documentation, Compliance and include support of the Quality Operations teams (NCMRs, Manufacturing Floor support) and site organization to conform and comply with regulations, internal policies, directives, and procedures to achieve and exceed the quality objectives expected by the customer and the organization.

What a typical day looks like:

• Management of the site's Quality System teams/processes to assure the conformance of all organization's regulatory and quality systems requirements.
• Optimize site Quality System processes and improvements of timeliness
• Manage customer SCAR process for investigation and response
• Manage Internal audit process (audit schedule, execution, response follow-up) and 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.).
• Provide support to any Quality or Operational area that requires help to implement Regulatory and Quality requirements into their processes.
• Participating in overall Quality and Site Operational Excellence/Improvement activities
• Develop training programs for internal users in subjects related to Regulations or Quality Systems.
• Execute the formation of Regulatory and Quality Systems skilled employees that help support the organization.
• Act as SME for medical device Quality Systems and engage in ongoing process improvements and system operations as needed
• Oversite of Layered Area/Process Audits
• 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:

• 6-10 years of Quality System Supervision or Management experience required in Medical Device (FDA CFR 820, ISO 13485, ISO 14971 and MDSAP)
• 5+ years of managerial experience
• 6+ years of CAPA experience
• Participation in lead roles (backroom/front room) of Regulatory Audits
• Familiarity with International regulatory requirements preferred
• Additional roles/experience in Quality Operations preferred
• Experience in Contract Manufacturing preferred

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

Job 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).

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