Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of iso 13485, iso 9001, fda regulations
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure 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 quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while fostering a culture where every associate owns quality.
Success in this role requires adherence to strict regulatory standards including EU MDR, ISO 13485, and FDA regulations while driving continuous improvement initiatives.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure 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, 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 root cause analysis techniques
Calm demeanor in fast-paced manufacturing settings
Commitment to diversity and inclusive work environment
Proficiency in data analysis practices
Key Requirements
Minimum bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
Auditing experience required
U.S. citizenship or work authorization not explicitly specified but US applicants mentioned