CAPA Manager

Flex • TX

84d

About The Position

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 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. 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.

Requirements

• Bachelor's degree in Engineering or related field or equivalent experience and training.
• 6-10 years of Quality System Supervision or Management experience required in Medical Device (preferably with FDA CFR 820, ISO 13485 and ISO 14971 experience).
• 5+ years of managerial experience.
• 6+ years of CAPA experience.
• Additional roles/experience in Quality Operations preferred.
• Experience in Contract Manufacturing preferred.

Responsibilities

• 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.

Benefits

• Full range of medical, dental, and vision plans.
• Life Insurance.
• Short-term and Long-term Disability.
• Matching 401(k) Contributions.
• Vacation and Paid Sick Time.
• Tuition Reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees