Director, Service & Repair Quality

📋 Description

• Lead and develop a world-class Service & Repair Quality org.
• Provide global leadership across sites in the US, Germany, Japan.
• Promote awareness of regulatory, quality, and customer reqs.
• Ensure quality systems are audited, updated, and improved.
• Apply global quality reqs: FDA, GMP, CAPA, ISO 13485, MDD, CMDCAS.
• Lead support during FDA, Notified Body, and reg inspections.

🎯 Requirements

• Bachelor’s degree in science or engineering; MS preferred.
• 10+ years in GMP-related med device or biotech manufacturing.
• 7+ years leading Quality teams at a corporate level.
• Strong knowledge of global quality systems and regs.
• Experience with FDA, Notified Body inspections.
• Solid understanding of QMS, GMP, CAPA, risk mgmt, SOPs.

🎁 Benefits

• Base salary $150,000–$258,750/year. Exact comp depends on location/experience.
• Long-term incentive program eligibility.
• Retirement: pension and 401(k).
• 120 hours vacation/year.
• Paid sick time and 13 paid holidays.
• Up to 40 hours of Work, Personal and Family Time.