The primary purpose of this role is to lead the manufacturing site or sites assigned 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 or sites assigned 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 Quality Supervisors, Quality Engineers, and individual performers to establish a culture of quality across the site.
This role requires specialized knowledge of quality system regulations such as ISO 13485, ISO 9001, Good Manufacturing Practices, and auditing experience to prevent and correct quality related gaps.
Matching Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and FDA 21CFR820 knowledge
Root cause analysis and CAPA leadership
Supplier quality audit experience
Team leadership and development skills
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Experience with EU MDR regulations
Strategic vision alignment skills
Fast-paced complex environment adaptability
Key Requirements
Bachelor's degree in engineering or related technical field
Master's degree preferred
Minimum 8 years in manufacturing with ISO/regulatory compliance
Prior supervisory or leadership experience required
Knowledge of Test Method development and Risk assessments