Manager Of Quality Assurance

ZOLL

Pittsburgh, Pennsylvania, United States
Base: $119,000.00 to $145,000.00; bonus: eligible ...
Fully remote
Fda quality management system regulation knowledge
Iso 13485 and iso 14971 expertise
Management of 20+ qa inspectors and engineers
This position directs all aspects of Quality Assurance to optimize risk, safety, financial, quality, and productivity objectives within a Class 3 PMA medical device company

Job Summary

  • This position directs all aspects of Quality Assurance to optimize risk, safety, financial, quality, and productivity objectives within a Class 3 PMA medical device company.
  • The role requires managing a staff of over 20 quality assurance inspectors and engineers while ensuring compliance with FDA regulations and international standards.
  • ZOLL offers a unique opportunity to impact patients' lives through innovative cardiac technologies while providing competitive compensation and comprehensive benefits.

Matching Summary

This position directs all aspects of Quality Assurance to optimize risk, safety, financial, quality, and productivity objectives within a Class 3 PMA medical device company.

Salary

Base: $119,000.00 to $145,000.00; Bonus: Eligible for annual bonus per company plan; Benefits: Comprehensive plans available at zollbenefits.com

Skills & Requirements

Must-have

  • FDA Quality Management System Regulation knowledge
  • ISO 13485 and ISO 14971 expertise
  • Management of 20+ QA inspectors and engineers
  • CAPA program and audit management experience
  • Nonconforming material process oversight

Nice-to-have

  • Advanced problem solving skills
  • Lean Six Sigma certification preferred
  • ASQ Certified CQE or CRE credentials
  • Development of best practices strategies
  • Trend analysis on quality data

Key Requirements

  • Bachelor's Degree required
  • Minimum 5 years management/leadership experience
  • Minimum 4 years medical device QA engineering experience preferred
  • In-depth knowledge of 21 CFR 820
  • ASQ certifications preferred (CQE, CRE, CQM)

Work Rights

Not specified

Tailored Resume

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