Bachelor's degree in engineering or technical field
3 years of quality management experience
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 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 Good Manufacturing Practices.
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 technical field
3 years of quality management experience
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 root cause analysis and CAPA
Familiarity with the Integer Production System
Excellent written and oral communication skills
Commitment to diversity and inclusive work environment
Key Requirements
Minimum bachelor's degree in engineering
3 years minimum experience in quality
Specialized knowledge of ISO 13485 and FDA 21CFR820