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 to ensure manufacturing site quality requirements are met
Job Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while promoting a diverse and inclusive work environment where mutual trust is shared.
Success in this role requires adherence to strict regulatory standards including EU MDR, ISO 13485, and FDA regulations while driving process improvements.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site quality requirements are met.
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 problem-solving skills
Experience with root cause analysis and data analysis
Calm demeanor in fast-paced complex environments
Commitment to fostering inclusive work environment
Proficiency in continuous improvement methodologies
Key Requirements
Minimum bachelor's degree in engineering
3 years minimum experience required
Specialized knowledge of medical device regulations