Quality Assurance Manager

We are seeking a QA Manager for a position involving extensive interaction with scientists and engineers in diverse work environments, including laboratories and manufacturing facilities, maintaining a clean workspace, and more.

Reporting to the Head of Regulatory Affairs, Clinical, and Quality in the company.

Role Description:

• Establishing and implementing a quality system supporting development and manufacturing within the company (majority of manufacturing processes occur within company facilities).
• Managing Design History File (DHF) and Device Master Record (DMR) per regulatory requirements in the US and Europe.
• Developing manufacturing documentation in collaboration with relevant bodies within the company (primarily R&D and engineering), including work instructions and production documents.
• Supporting QC processes.
• Managing CAPA (Corrective and Preventive Actions).
• Managing internal audits and supplier audits.
• Conducting employee training.

Role Requirements:

• Experience in the quality field of medical devices - mandatory.
• Engineering/Scientific degree - mandatory.
• Experience in establishing quality systems in the medical device field - an advantage.
• Experience in quality testing and employee training - an advantage.
• Familiarity with statistical methods, risk management, root cause analysis, and process validations.
• Experience working in clean room environments - an advantage.
• Familiarity with regulatory submissions and requirements - an advantage.

Required Skills:

• 5+ years of experience.
• Self-learning ability.
• Ability to work in a dynamic, multitasking environment.
• Data processing and analysis skills.
• Proficient in English, both verbal and written.