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, Environmental Management Systems, and FDA regulations while driving process improvements to enable accurate and efficient department execution.
This role requires embedding a culture of quality where every associate owns their quality responsibilities, supported by standard data analysis practices and active participation in corrective actions.
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 manage performance
Nice-to-have
Strong bias for action and decision making
Experience with root cause analysis and data analysis
Calm demeanor in fast-paced complex environments
Commitment to diversity and inclusive work environment
Ability to drive continuous improvement initiatives
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 manufacturing quality functions