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 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 promoting a diverse and inclusive work environment where mutual trust is shared.
Success in this role requires adherence to strict regulatory standards including EU MDR, ISO 13485, and Good Manufacturing Practices 21CFR820.
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 related technical field
3 years of experience in quality management
Knowledge of ISO 13485, ISO 9001, and FDA regulations
Experience with CAPA and non-conforming material processes
Ability to lead and develop a team of quality professionals
Nice-to-have
Strong bias for action and problem-solving skills
Experience with risk-based process control approaches
Excellent written and oral communication skills
Ability to work independently in a fast-paced environment
Commitment to fostering an inclusive work culture
Key Requirements
Minimum bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of quality system regulations and auditing