Director, Quality (buffalo Campus)

The Integer Group

Buffalo, NY, US
Base: $150,750 - $221,100; bonus/equity: cash-base...
Not specified (assumed hybrid or onsite based on job nature)
10+ years experience in regulated manufacturing
6+ years management experience required
Expertise in 21cfr820 iso13485 eu mdr
The Integer Group is seeking a Director of Quality for its Buffalo campus, aiming to enhance quality leadership within its manufacturing sites for medical devices. The role requires significant experience in quality management within regulated environments, focusing on customer satisfaction, compliance, and fostering a culture of quality and collaboration

Job Summary

  • The role provides strategic quality leadership to ensure sites meet customer requirements while maintaining compliance with applicable quality and regulatory standards.
  • Success will be measured through site participation in safety initiatives, achievement of quality and delivery metrics, and continuous improvement contributions.
  • Employees are eligible for a comprehensive benefits package including medical, dental, vision, 401(k) matching, and stock awards at the Director level.

Matching Summary

Match Score: 85

The Integer Group is seeking a Director of Quality for its Buffalo campus, aiming to enhance quality leadership within its manufacturing sites for medical devices. The role requires significant experience in quality management within regulated environments, focusing on customer satisfaction, compliance, and fostering a culture of quality and collaboration.

Salary

Base: $150,750 - $221,100; Bonus/Equity: Cash-based incentive program and stock awards for Directors; Benefits: Medical, dental, vision, 401(k) match, parental leave

Skills & Requirements

Must-have

  • 10+ years experience in regulated manufacturing
  • 6+ years management experience required
  • Expertise in 21CFR820 ISO13485 EU MDR
  • Strong knowledge of GMP and auditing
  • Experience with Design Controls and CAPA

Nice-to-have

  • Master's degree preferred
  • ASQ Quality Manager or Six Sigma Black Belt
  • Emotional intelligence and talent development
  • Proactive customer experience mindset
  • Lean and 5S implementation experience

Key Requirements

  • Bachelor's degree in quality engineering or related field
  • Current passport and ability to secure visas
  • Minimum 10 years total experience in medical device manufacturing
  • Minimum 6 years in management roles
  • Expertise in statistical concepts like DOE and capability studies

Work Rights

Must have current passport and ability to secure appropriate visas

Tailored Resume

Cover Letter