What are the responsibilities and job description for the Supplier Quality Assurance Manager position at Interactive Resources Ir?
- Location:Gainesville, Florida
Type:
Direct HireJob #11270
Salary:
$145000
Our client, a manufacturer with a global footprint, is seeking a Supplier Quality Assurance Manager to lead both compliance and performance of external their external partners to ensure the meet the rigorous requirements in a highly regulated industry.
Required Education/Experience:
- Bachelor’s Degree in a relevant discipline with 10 years of experience in an FDA regulated environment with proven supplier quality management.
- Prior success leading the development or significant remediation of a supplier quality program involving supplier requirements, selection, qualification, approval, and ongoing monitoring in compliance with FDA regulations
- Overseen Supplier Corrective Action Reports (SCARs) to determine effectiveness and ability to create closure.
- Develop and maintain the criteria for supplier audit schedules and lead the audits when required.
- Technical sound and demonstrating knowledge of SPC, process qualifications, and failure mode effects analysis
Preferred Education/Experience:
- Undergraduate degree in engineering or a Master in relevant discipline with direct experience developing supplier quality programs in an ISO 13485 regulated environment
- ISO 13485 Lead Auditor Certification
- Ability to understand technical drawings and the application of geometric dimensioning and tolerances
- Experience working with or managing services contractors through remediation projects
- Overseen supplier quality program on a global scale in major markets in such as Europe, Asia, and India
Salary : $145,000