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 quality professionals
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 quality professionals.
You will ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and FDA regulations while driving process improvements.
This position 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 and providing daily direction to quality professionals.
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 root cause analysis
Ability to lead and develop a team of quality professionals
Nice-to-have
Strong bias for action and decision making
Experience with the Integer Production System
Ability to work independently in a fast-paced 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
Minimum 3 years of relevant experience
Specialized knowledge of EU MDR, ISO 13485, ISO 9001, and 21CFR820
Auditing experience required
U.S. citizenship or work authorization not explicitly specified but US applicants mentioned