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 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 compliance to the established Quality Management System (QMS) and drive process improvements to enable the department to execute at a more accurate and efficient level.
As part of your responsibilities, you will establish objectives for your team members and provide active support for their Individual Development Plans as a roadmap to professional growth.
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, ISO 9001, and FDA regulations
Experience with CAPA and root cause analysis
Ability to lead and develop a team of quality professionals
Nice-to-have
Strong bias for action and decision making
Experience with the Integer Production System
Excellent written and oral communication skills
Ability to work independently in a fast-paced environment
Commitment to fostering an inclusive work environment
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, and 21CFR820
Auditing experience required
Technical aptitude in manufacturing quality or supplier quality