Director, Quality
On-siteNew Ross, Leinster, Ireland
Job Summary
Director, Quality leading the quality organization at a Medical Device contract manufacturer. Provides energetic and strategic quality leadership to assigned manufacturing site(s), ensuring compliance with customer requirements and regulatory standards, elevating the local QMS within the global Inte ger QMS, and driving quality initiatives to reinforce a culture of quality, customer experience, and innovation. Builds and develops high-performing Quality teams, serves as the management representative for the local QMS, interfaces with customers on quality escalations, approves key quality records, and partners with R&D and manufacturing to enable robust design transfer, process controls, CAPA, and continuous improvement. Emphasizes built-in quality, data-driven improvements, and alignment with Integer’s manufacturing excellence and 5S standards while managing budget and cross-site quality resolution. Requires experience in regulated manufacturing, knowledge of ISO 13485, ISO 9001, 21 CFR 820, EU MDR, and strong problem-solving and communication skills; limited travel required; travel and visa readiness for international locations.
Required Qualifications
- Bachelor’s degree in a quality engineering or related field; Master’s degree preferred
- Minimum 10+ years of experience, including 6+ years in management in a Medical Device or other regulated manufacturing environment
- Specialized knowledge: 21CFR820, ISO13485, ISO9001, EU MDR, GMP, auditing, design controls and statistical concepts (DOE, capability studies, validations)
- Strong written and verbal communication skills
- High EI and talent development experience
- Limited travel (less than 25%), passport and visa eligibility for international travel
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