QA Director Medical device

קריית ביאליק, ישראל

תיאור

Conduct internal and external audits to ensure compliance with quality standards.

Develop and write quality procedures and documentation.

Support registration processes and adhere to MDR regulations.

Lead the implementation of quality standards within the company.

Draft protocols and reports, providing thorough documentation of processes.

Support validation processes and verifications.

Manage the quality system to ensure effectiveness and continuous improvement.

Simultaneously handle multiple tasks and prioritize efficiently.

דרישות

Bachelor's degree in Biotechnology, Life Sciences, Biomedical Engineering, or a relevant field.
Familiarity with ISO 13485 requirements and European regulatory requirements (MDR).
Certified Quality Engineer (ICQE/CQE) - an advantage.
Experience in preparing and guiding external audits is mandatory.
Experience working with Notified Bodies.
Ability to work with various interfaces and stakeholders.
Proficient in English (native level) and knowledge of Russian is an advantage.
Strong team collaboration and independent work capabilities.
Proven experience in a quality engineering role, preferably in the medical device industry.
In-depth understanding of quality management systems and regulatory compliance.
Excellent organizational and multitasking skills.
Strong communication and interpersonal skills.
Proactive approach with a focus on problem-solving.
The position is open to both male and female candidates.