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 to established Quality Management Systems including FDA regulations, ISO standards, and environmental requirements while driving process improvements.
This position requires embedding a culture of quality where associates own their work, supported by data analysis practices and root cause investigation for product failures.
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 Quality Management Systems (QMS)
Ability to lead teams and drive process improvements
Nice-to-have
Strong bias for action and decision making
Positive can-do attitude with failure not an option
Experience with EU MDR and Good Documentation Practices
Ability to work independently in a fast-paced environment
Effective written and oral communication skills
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
U.S. Applicants: Equal Opportunity Employer status applies