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, fostering a culture where everyone owns quality.
This role requires specialized knowledge of quality system regulations such as EU MDR, ISO 13485, ISO 9001, and Good Manufacturing Practices 21CFR820 along with auditing experience.
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 ISO 9001 knowledge
FDA 21 CFR 820 regulatory compliance
Root cause analysis and CAPA leadership
Team leadership and development skills
Supplier quality audit experience
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Master's degree in engineering
EU MDR regulatory knowledge
Hoshin planning experience
Positive can-do attitude
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 8 years experience in manufacturing environment
Prior supervisory or leadership experience required
Knowledge of statistical analysis and capability assessments