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, establishing a culture of quality across the site.
This role requires specialized knowledge of EU MDR, ISO standards, Good Manufacturing Practices, and experience with design control, production control, and risk assessments.
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
ISO 13485 and ISO 9001 compliance
FDA regulations and 21CFR820 knowledge
Root cause analysis and CAPA management
Supplier quality audits and internal QMS audits
Team leadership and development experience
Manufacturing excellence culture implementation
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Strategic vision creation skills
Fast-paced complex work environment adaptability
Diverse and inclusive work environment promotion
Key Requirements
Bachelor's degree in engineering or related technical field (Master's preferred)
Minimum 8 years of experience in manufacturing with ISO/regulatory governance
Prior supervisory or leadership experience required
Knowledge of Six Sigma, ASQ certifications, or similar quality credentials
Experience with Test Method development and Product/Process Validation