Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of iso 13485 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, FDA regulations, and other regulatory requirements while driving process improvements to enable accurate and efficient department execution.
As an element of our belief that we all Own Quality, you will engrain a culture of quality amongst your team and support internal and external quality audit activities.
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 and FDA regulations
Experience with Quality Management Systems (QMS)
Ability to lead and develop quality teams
Nice-to-have
Strong bias for action and decision making
Experience with EU MDR and 21CFR820
Calm demeanor in fast-paced environments
Cross-functional consensus building skills
Commitment to inclusive work environment
Key Requirements
Minimum bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of quality system regulations and standards
Auditing experience required
Technical aptitude for quality engineering disciplines