CAPA Manager
CAPA Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Summary
To support our extraordinary teams who build great products and contribute to our growth were 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 organizations 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 were looking to add to our team:
- Bachelors 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
#LI-EA1
EA42
SS26
AA01
CH12
MS14
CC11
What youll receive for the great work you provide:
- 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
Job Category
QualityIs Sponsorship Available
NoFlex 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. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well 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).Required Experience:
Manager
Employment Type
Full-Time
