Senior Manager, Quality

Integer

Hudson, MA, United States
Base: $150,000 - $220,220; bonus/equity: cash-base...
Not specified (assuming "onsite" based on the nature of the role and responsibilities)
Quality management system leadership
Regulatory compliance with fda and iso standards
Root cause analysis and problem solving
Integer is seeking a Senior Manager of Quality to lead its manufacturing site’s quality management system, ensuring compliance with regulatory standards while fostering a culture of quality and continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and possess strong leadership skills. The position offers competitive compensation and a comprehensive benefits package

Job Summary

  • The role leads the manufacturing site quality function to meet customer requirements and regulatory compliance while driving continuous improvement and innovation.
  • The company offers a comprehensive benefits package including medical, dental, vision, life insurance, 401(k) with matching, paid time off, and parental leave.
  • The position promotes a culture of quality ownership, teamwork, and associate engagement aligned with Integer’s values and strategic imperatives.

Matching Summary

Match Score: 85

Integer is seeking a Senior Manager of Quality to lead its manufacturing site’s quality management system, ensuring compliance with regulatory standards while fostering a culture of quality and continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and possess strong leadership skills. The position offers competitive compensation and a comprehensive benefits package.

Salary

Base: $150,000 - $220,220; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 401(k) with match, paid time off

Skills & Requirements

Must-have

  • Quality Management System leadership
  • Regulatory compliance with FDA and ISO standards
  • Root cause analysis and problem solving
  • CAPA and complaint handling management
  • Supplier and internal quality audits
  • Team leadership and development
  • Quality metrics and continuous improvement

Nice-to-have

  • Cross functional consensus building
  • Diverse and inclusive work environment
  • Strategic planning and budget management
  • Manufacturing Excellence culture
  • Positive and calm demeanor under pressure

Key Requirements

  • Bachelor’s degree in engineering or related technical field
  • Minimum 8 years manufacturing experience with ISO and regulatory compliance
  • Prior supervisory or leadership experience
  • Quality certifications such as Six Sigma Green Belt or ASQ certifications
  • Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820 regulations
  • Experience with test method development and validation protocols

Work Rights

Not specified

Tailored Resume

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