Base salary not specified; cash-based incentive pr...
Not specified
Iso 13485 and iso 9001 compliance
Fda regulations and 21cfr820 knowledge
Root cause analysis and capa management
Integer is seeking a Senior Manager of Quality to lead and enhance their quality management systems at manufacturing sites for medical devices. The ideal candidate should possess extensive experience in quality management within a regulated manufacturing environment, along with strong leadership skills
Job Summary
This role leads the manufacturing site's quality function to ensure compliance with customer requirements and global quality management system policies.
The position requires managing the entire local quality management system including CAPA, complaint handling, design control, and supplier quality audits.
Candidates will benefit from a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with company matching.
Matching Summary
Match Score: 85
Integer is seeking a Senior Manager of Quality to lead and enhance their quality management systems at manufacturing sites for medical devices. The ideal candidate should possess extensive experience in quality management within a regulated manufacturing environment, along with strong leadership skills.
Salary
Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, life insurance, and 401(k) match
Skills & Requirements
Must-have
ISO 13485 and ISO 9001 compliance
FDA regulations and 21CFR820 knowledge
Root cause analysis and CAPA management
Supplier quality audits and internal QMS audits
Team leadership and development of quality professionals
Design control and production process management
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Experience with EU MDR regulations
Strong communication and cross-functional collaboration
Ability to work in a fast-paced environment
Commitment to diversity and inclusion culture
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 8 years of experience in manufacturing with ISO/regulatory governance
Prior supervisory or leadership experience required
Specialized knowledge of Good Manufacturing Practices (GMP)
Auditing experience and statistical analysis skills