Supplier Quality Assurance Manager

• Location:
  Gainesville, Florida
Type:
Direct Hire

Job #11270

Salary:
$145000

Location Type: On-Site

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