Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of iso 13485, iso 9001, and fda regulations
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met
Job Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while driving process improvements and ensuring compliance with QMS and regulatory standards.
Success in this role requires embedding a culture of quality where every team member owns their contribution to customer success and product excellence.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of ISO 13485, ISO 9001, and FDA regulations
Experience with CAPA and non-conforming material investigations
Ability to lead and develop a team of quality professionals
Nice-to-have
Strong bias for action and problem-solving skills
Experience with the Integer Production System
Ability to work in a fast-paced complex environment
Excellent written and oral communication skills
Commitment to fostering an inclusive work environment
Key Requirements
Minimum Bachelor's degree in engineering or related technical field
3 years of minimum experience in quality functions
Specialized knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820