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 (QMS) and drive process improvements using a risk-based approach to achieve site performance goals.
The company values include customer focus, innovation, collaboration, inclusion, candor, and integrity, creating a culture that unifies the team for long-term success.
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
Bias for action and decision making
Strong communication and interpersonal skills
Experience with EU MDR compliance
Leadership in fast-paced manufacturing environments
Commitment to diversity and inclusion culture
Key Requirements
Minimum bachelor's degree in engineering
3+ years of relevant experience
Specialized knowledge of medical device regulations