Senior Manager, Quality

636

Base salary not specified; cash-based incentive pr...
Not specified
Iso 13485 and iso 9001 compliance
Fda 21 cfr 820 regulations
Root cause analysis and capa management
Integer is seeking a Senior Manager of Quality to lead and enhance their quality management systems in a manufacturing environment focused on medical devices. The ideal candidate will possess extensive experience in quality management, regulatory compliance, and leadership within a manufacturing setting

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 are responsible for the entirety of the local quality management system which includes Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, and Supplier Quality Audits.
  • Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy, along with a comprehensive benefits package including medical, dental, vision, and 401(k) matching.

Matching Summary

Match Score: 85

Integer is seeking a Senior Manager of Quality to lead and enhance their quality management systems in a manufacturing environment focused on medical devices. The ideal candidate will possess extensive experience in quality management, regulatory compliance, and leadership within a manufacturing setting.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) matching

Skills & Requirements

Must-have

  • ISO 13485 and ISO 9001 compliance
  • FDA 21 CFR 820 regulations
  • Root cause analysis and CAPA management
  • Supplier quality audits and internal QMS audits
  • Team leadership and development
  • Design control and production control

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Hoshin planning experience
  • Diverse and inclusive work environment promotion
  • Fast-paced complex decision making
  • Strategic vision alignment

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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