CAPA Manager

CAPA Manager

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

Reporting to the Senior Quality Systems / Compliance Manager the CAPA Manager role will be responsible for a team of medical device Quality professionals performing Quality Systems and CAPA functions. These 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 CAPA team and process to assure the conformance of all organization's regulatory and quality systems requirements.
• Suggests and debates alternative methods and procedures in solving problems.
• Provide support to any Quality or Operational area with required CAPA investigations.
• Participating in overall Quality and Site Operational Excellence / Improvement activities.
• Develop / maintain CAPA training programs.
• Execute the formation of Regulatory and Quality Systems skilled employees that help support the organization.
• Interface with customers on technical / quality issues and improvement initiatives.
• Participate as a key member for all internal and external audits activities.
• Follow up on internal and external corrective actions to ensure timely implementation and validate their effectiveness.
• Supports as part of the Designated Complaint Handling Unit of the site.

The experience we're looking to add to our team :

What you'll receive for the great work you provide :

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 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).