Base: not specified; bonus/equity: cash-based ince...
Not specified
8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda regulations 21cfr820 expertise
Integer is seeking a Senior Manager, Quality to lead its quality management initiatives in a manufacturing environment focused on medical devices. The ideal candidate will have extensive experience in quality systems and regulatory compliance, with a strong emphasis on leadership and team development
Job Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
You will provide leadership for a team of Quality function professionals, including supervisors, engineers, and individual performers, establishing a culture where everyone owns quality.
Our total rewards program includes base salary, cash-based incentives, comprehensive medical benefits, and immediate eligibility for a 401(k) plan with company matching contributions.
Matching Summary
Match Score: 85
Integer is seeking a Senior Manager, Quality to lead its quality management initiatives in a manufacturing environment focused on medical devices. The ideal candidate will have extensive experience in quality systems and regulatory compliance, with a strong emphasis on leadership and team development.
Salary
Base: Not specified; Bonus/Equity: Cash-based incentive program supporting pay-for-performance; Benefits: Comprehensive package including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) match
Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and ISO 9001 knowledge
FDA regulations 21CFR820 expertise
Root cause analysis and CAPA leadership
Team supervision and development skills
Supplier quality audit experience
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Bachelor's degree in engineering
Master's degree preferred
Hoshin planning experience
Diverse and inclusive culture champion
Key Requirements
Minimum bachelor's degree in engineering or related technical field
At least 8 years of experience in manufacturing with ISO/regulatory governance
Prior supervisory or leadership experience required
Knowledge of EU MDR, Good Manufacturing Practices, and auditing