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 company policies, safety requirements, and regulatory standards including FDA regulations 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 related technical field
3 years of experience in quality management
Knowledge of ISO 13485, ISO 9001, and FDA regulations
Experience with Quality Management Systems (QMS)
Ability to lead teams of quality engineers and technicians
Nice-to-have
Strong bias for action and problem-solving skills
Experience with root cause analysis and CAPA
Ability to work in a fast-paced complex environment
Commitment to fostering an inclusive work culture
Proficiency in data analysis practices
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 for manufacturing quality functions