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 EU MDR, ISO 13485, and FDA regulations while leading corrective and preventive action investigations.
This position requires embedding a culture of quality where associates own their work, supported by standardized problem-solving methodologies and continuous improvement 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, ISO 9001, and FDA regulations
Experience with CAPA and non-conforming material processes
Ability to lead and develop a team of quality professionals
Nice-to-have
Bias for action and decision making skills
Strong communication and interpersonal abilities
Experience with risk-based process control approaches
Positive can-do attitude in fast-paced environments
Cross-functional consensus building capabilities
Key Requirements
Minimum bachelor's degree in engineering
3 years minimum experience required
Specialized knowledge of medical device regulations