The Staff Medical Device Quality Systems Engineer is responsible for the strategic oversight, development, and continuous improvement of the Medical Quality Management System (MQMS)
Job Summary
The Staff Medical Device Quality Systems Engineer is responsible for the strategic oversight, development, and continuous improvement of the Medical Quality Management System (MQMS).
This role ensures compliance with global regulatory requirements and drives quality system maturity across the organization.
The Staff Engineer leads cross-functional initiatives, and influences quality culture and regulatory readiness at a global scale.
Matching Summary
The Staff Medical Device Quality Systems Engineer is responsible for the strategic oversight, development, and continuous improvement of the Medical Quality Management System (MQMS).
Skills & Requirements
Must-have
ISO 13485
21 CFR 820
EU MDR
CAPA process
Internal audits
Document control
Change management
Management review
Nice-to-have
Influences quality culture
Drives data-driven improvements
Mentors and coaches engineers
Key Requirements
Bachelor’s degree in Engineering, Life Sciences, or related technical field
Minimum 5+ years of experience in medical device industry
Expert-level understanding of global regulatory requirements
Proven leadership in developing and managing quality systems
Demonstrated success in leading audits and inspections
Strong knowledge of FDA 510(k), PMA, and submission maintenance
Advanced proficiency in quality tools and methodologies