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.
You are responsible for the entirety of the local quality management system which includes Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, and Supplier Quality Audits.
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
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 and cross-functional consensus building
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 degree preferred
Minimum 8 years of experience in manufacturing environment
Prior supervisory or leadership experience required
Knowledge of EU MDR and Good Documentation Practices
Experience with Test Method development and risk assessments