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 adherence to Quality Management Systems, Environmental Management Systems, and FDA regulations while driving process improvements to enable accurate and efficient department execution.
This position requires embedding a culture where every associate owns quality, supporting corrective actions, and leading complaint investigations to prevent re-occurrence.
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
3 years of quality experience
ISO 13485 and FDA regulations knowledge
Quality Management System (QMS) compliance
Root cause analysis and CAPA management
Nice-to-have
Strong leadership and team development skills
Bias for action and problem-solving
Experience with EU MDR standards
Ability to work in fast-paced environment
Cross-functional collaboration expertise
Key Requirements
Minimum bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of ISO 13485, ISO 9001, and 21CFR820