Position Summary
The Director of Quality Systems will play a key role in supporting this subsidary of one of the largest medical device companies in the world. There extensive experience in quality systems will be a needed in helping grow this medical device company. This position requires hands-on expertise in process validation, quality system management, and Endovascular experience!
The ideal candidate is an experienced Manager/Director who thrives in a dynamic environment, can drive projects, lead a team, and provides mentorship to the team.
Key Responsibilities
- Extensive experience in the medical device industry
- Endovascular (EVAR) experience
- Quality Management Systems expertise
Oversee and maintain quality systems, including change control, CAPA, document control, and risk management processes (e.g., FMEA).
Support internal and external audits, including preparation, response, and follow-up actions.
Conduct gap assessments and remediation activities to ensure compliance with notified body and regulatory requirements (ISO 13485, FDA QSR, CE Mark).
Lead quality system initiatives to improve efficiency and effectiveness.
Qualifications
Bachelor's degree in Engineering, Science, or a related technical field.
Preferred:
Experience supporting notified body audits and FDA inspections.
Knowledge of supplier quality management and lean manufacturing principles.
Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green Belt/Black Belt.
Background in catheter manufacturing, process validations, or medical device product development.
