Overview
As the Head of Quality Assurance, you will be responsible for leading and overseeing all quality assurance (QA) activities across the company. You will ensure compliance with ISO 13485, EU MDR (2017/745), FDA 21 CFR Part 820, and other applicable regulations. This is a strategic leadership role requiring cross-functional collaboration, strong regulatory knowledge, and an unwavering commitment to quality and patient safety.
Responsibilities
* Lead and manage the Quality Assurance department, including hiring, training, and performance management of QA staff.
* Oversee and maintain the Quality Management System (QMS) in compliance with ISO 13485, EU MDR, and FDA requirements.
* Develop, implement, and continuously improve QA policies, processes, and procedures.
* Ensure readiness and successful outcomes of internal and external audits (e.g., Notified Body, FDA, customers).
* Collaborate with R&D, Regulatory Affairs, Manufacturing, and Supply Chain teams to support product development, validation, and release.
* Manage CAPA, nonconformance, and complaint handling processes.
Qualifications
* Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
* Minimum 8–10 years of experience in Quality Assurance within the medical device industry.
* Proven leadership experience in a QA management role.
* Deep knowledge of ISO 13485, EU MDR, and FDA QSR (21 CFR 820).
* Experience with Class II and/or Class III medical devices is highly preferred.
* Strong knowledge of quality tools (e.g., CAPA, FMEA, root cause analysis).
* Excellent communication skills in German & English.
#J-18808-Ljbffr