Global Quality Director - Med Device Manufacturing

integer; New Ross; On-site; EUR 90,000 - 130,000; Full time

Job summary

Integer is seeking an experienced Quality leader to head the site Quality Management System across our manufacturing operations. You will ensure compliance with 21 CFR 820, ISO13485, ISO9001, EU MDR, and drive a culture of quality, safety and reliability.

You will build and mentor a high-performing team, lead change management to embed quality into products and processes, and serve as the primary customer interface for quality matters, including CAPAs, NCRs and product transfers.

Qualifications

• Bachelor’s degree in quality engineering or related field; Master’s preferred.
• 10+ years of experience, including 6+ years in management in a Medical Device or regulated manufacturing environment.

Responsibilities

• Provide energetic and strategic quality leadership to the manufacturing site(s) assigned to.
• Elevate the impact of the local QMS within the overarching Integer QMS and drive quality initiatives.
• Influence and drive change management to design quality into product and process through robust characterization and capability activity.
• Serve as the management representative accountable for the full local QMS.
• Build and lead a high‑performing Quality team, fostering company pride.
• Develop a proactive site approach to customer experience, fostering trust and handling customer quality escalations.
• Review and approve key quality records including CAPAs, NCRs, change notices, and reports.

Skills

Quality leadership

Regulatory knowledge

Problem solving

Communication

Emotional intelligence

Travel willingness

Education

Bachelor’s degree in quality engineering or related field

Master’s degree preferred

Tools

ASQ Certification (QM/Engineer)

Six Sigma Black Belt

Job description

Integer is seeking an experienced Quality leader to head the site Quality Management System across our manufacturing operations. You will ensure compliance with 21 CFR 820, ISO13485, ISO9001, EU MDR, and drive a culture of quality, safety and reliability.

You will build and mentor a high-performing team, lead change management to embed quality into products and processes, and serve as the primary customer interface for quality matters, including CAPAs, NCRs and product transfers.