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 position requires embedding a culture of quality where every team member owns their role in achieving customer success and maintaining high standards in medical device manufacturing.
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
Experience with EU MDR and Good Documentation Practices
Calm demeanor in fast-paced complex environments
Ability to work independently and collaboratively
Positive can-do attitude with failure not an option mindset
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 and effective communication skills