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 and providing daily direction to ensure 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 and providing daily direction to ensure quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while promoting a diverse and inclusive work environment where team members feel supported.
Success in this role requires adherence to strict regulatory standards including FDA regulations, ISO 13485, and Good Manufacturing Practices while driving process improvements.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables and providing daily direction to ensure 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 processes
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
Excellent written and oral communication skills
Ability to work independently in a fast-paced environment
Commitment to diversity and inclusive work environment
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, 21CFR820
Auditing experience required
Technical aptitude for quality systems and data analysis