The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures
Job Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures.
You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers, establishing a culture of quality across the site.
This role requires specialized knowledge with respect to quality system regulations such as EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820, and auditing experience.
Matching Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures.
Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and ISO 9001 knowledge
FDA 21 CFR 820 regulations
Root cause analysis expertise
CAPA and complaint handling
Team leadership and development
Supplier quality audits
Nice-to-have
Six Sigma Green Belt certification
ASQ Quality Auditor certification
EU MDR familiarity
Hoshin planning experience
Diverse and inclusive culture champion
Strategic vision alignment
Fast-paced decision making
Key Requirements
Bachelor's degree in engineering or related technical field
Master's degree preferred
Minimum 8 years in manufacturing with ISO/regulatory focus
Prior supervisory or leadership experience required
Quality specific certifications (Six Sigma, ASQ) valued