Senior Manager, Quality

Integer

Base: not specified; bonus/equity: cash-based ince...
8 years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda regulations 21cfr820 expertise
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

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, establishing a culture of quality amongst your team and across the site.
  • Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy, along with a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

Matching 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.

Salary

Base: Not specified; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive package including medical, dental, vision, 401(k) matching, and 10 days holidays

Skills & Requirements

Must-have

  • 8 years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA regulations 21CFR820 expertise
  • Root cause analysis skills
  • Team leadership and development
  • CAPA and complaint handling

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Bachelor's degree in engineering
  • Master's degree preferred
  • Diverse and inclusive work environment
  • Fast-paced complex work environment

Key Requirements

  • Minimum bachelor's degree in engineering or related technical field
  • At least 8 years of experience in manufacturing environment
  • Prior supervisory or leadership experience required
  • Knowledge of EU MDR and Good Documentation Practices
  • Auditing experience required

Work Rights

Not specified

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