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
This role serves as a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met
Job Summary
This role serves as a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met.
The position requires supervising, coaching, and directing a team of quality engineers and technicians while driving process improvements and ensuring compliance with QMS and FDA regulations.
Success in this role involves embedding a culture of quality ownership, managing corrective actions, and supporting strategic imperatives like Manufacturing Excellence.
Matching Summary
This role serves as 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 Lean Manufacturing and continuous improvement
Excellent written and oral communication skills
Ability to work independently in a fast-paced environment
Commitment to fostering an inclusive and diverse work culture
Key Requirements
Minimum Bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of EU MDR, ISO 13485, ISO 9001, and 21CFR820