The primary purpose of this role is to lead the manufacturing site to ensure they meet customer requirements while remaining in compliance with associated quality management system policies
Job Summary
The primary purpose of this role is to lead the manufacturing site to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
You will provide leadership for a team of Quality function professionals, including supervisors, engineers, and individual performers, while championing the evolution of the local Quality System.
This role requires specialized knowledge of quality system regulations such as ISO 13485, ISO 9001, and Good Manufacturing Practices to drive process improvements and prevent quality gaps.
Matching Summary
The primary purpose of this role is to lead the manufacturing site to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
Skills & Requirements
Must-have
ISO 13485 and FDA 21 CFR 820 compliance
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 or ASQ certifications
Experience with EU MDR regulations
Strategic vision alignment and Hoshin planning
Fostering diverse and inclusive work culture
Mentoring associates on professional growth
Key Requirements
Bachelor's degree in engineering or related technical field
Master's degree preferred
Minimum 8 years experience in manufacturing with ISO/regulatory governance
Prior supervisory or leadership experience required
Knowledge of Test Method development and risk assessments (pFMEAs, dFMEAs)