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Director of Quality Management

2 months ago


Hollister, California, United States Fortive Corporation Full time
Job Summary

We are seeking a highly skilled and experienced Director of Customer Quality to join our team at Fortive Corporation. This is a critical role that requires a strong background in quality management, regulatory compliance, and leadership.

Key Responsibilities
  • Develop and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
  • Lead a team of quality professionals to investigate and resolve customer complaints in a timely and effective manner.
  • Collaborate with cross-functional teams to ensure quality considerations are integrated into all stages of the product lifecycle.
  • Develop and maintain policies and procedures for supplier quality management, complaint processing, and regulatory reporting.
  • Provide oversight and direction for all quality-related risk management practices to proactively address potential threats to product quality.
  • Drive continuous improvement metrics and scorecards to support supplier performance management.
  • Communicate business-related issues or opportunities to senior management.
Requirements
  • Bachelor's Degree in Engineering, Business, Regulatory, or Operations Management.
  • Minimum of 7+ years of business experience in quality and regulatory compliance in medical devices.
  • Knowledge of QMS, ISO 13485, EU MDR, and GMPs.
  • Proven track record of working remotely and partnering globally.
  • Ability to communicate clearly and concisely across all levels of the company.
  • Ability to cultivate an effective multi-functional, cross-region, cross-company team environment.
Working Conditions

This role requires up to 30% travel, both domestically and internationally. The employee must be able to work in a fast-paced environment and prioritize multiple activities and responsibilities.