Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of iso 13485 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 adherence to the Quality Management System (QMS), Environmental Management Systems (EMS), and U.S. Food and Drug Administration (FDA) regulations while driving process improvements.
This position requires embedding a culture where every team member owns quality, utilizing data analysis to establish root causes for product and process failures.
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 and FDA regulations
Experience with Quality Management Systems (QMS)
Ability to lead and develop quality teams
Nice-to-have
Strong bias for action and problem-solving skills
Experience with continuous improvement methodologies
Ability to work in a fast-paced environment
Effective written and oral communication skills
Commitment to diversity and inclusion culture
Key Requirements
Minimum bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of EU MDR, ISO 9001, and 21CFR820
Auditing experience required
U.S. citizenship not explicitly required but US applicants mentioned