This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System
Job Summary
This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System.
The manager is responsible for preventing and correcting quality gaps while driving process improvements to enable accurate and efficient organizational execution.
Candidates must possess at least 8 years of experience in a manufacturing environment with ISO standards governance and prior supervisory leadership experience.
Matching Summary
This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System.
Skills & Requirements
Must-have
ISO 13485 and ISO 9001 compliance
FDA 21 CFR Part 820 regulations
Root cause analysis and CAPA management
Supplier quality audits and internal QMS audits
Team leadership and development of quality staff
Design control and production process controls
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Experience with EU MDR requirements
Hoshin planning and strategic alignment
Diverse and inclusive work environment champion
Fast-paced complex decision making skills
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 8 years of manufacturing experience
Prior supervisory or leadership experience required