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The Integer Group is seeking a Sr. Quality Manager to lead quality assurance efforts at their manufacturing sites, ensuring compliance with quality management systems and driving continuous improvement. The ideal candidate will possess strong leadership skills and extensive experience in quality management within a regulated manufacturing environment, particularly in medical device or related industries.
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Job Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures.
You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers, while establishing a culture of quality across the site.
This role requires specialized knowledge of quality system regulations such as EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820, and auditing experience.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Sr. Quality Manager to lead quality assurance efforts at their manufacturing sites, ensuring compliance with quality management systems and driving continuous improvement. The ideal candidate will possess strong leadership skills and extensive experience in quality management within a regulated manufacturing environment, particularly in medical device or related industries.
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Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and ISO 9001 knowledge
FDA 21 CFR 820 regulations
Root cause analysis expertise
CAPA and complaint handling
Supplier quality audits
Team leadership and development
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
EU MDR experience
Hoshin planning participation
Diverse and inclusive culture champion
Fast-paced decision making
Cross-functional consensus building
Key Requirements
Bachelor's degree in engineering or related technical field
Master's degree preferred
Minimum 8 years in manufacturing with ISO/regulatory focus
Prior supervisory or leadership experience required
Knowledge of Test Method development and validation protocols