Informacje o stanowisku

Medical Device Auditor - Ophthalmic Non-Active Devices

Responsibilities

• Audit Planning: Developing audit schedules and preparing for audits in line with relevant standards and regulations.
• Conducting Client Audits: Verifying compliance of processes and documentation with quality and regulatory requirements.
• Post-Audit Documentation: Preparing reports that include audit findings, recommendations, and necessary corrective actions.
• Professional Development: Participating in training and courses to keep knowledge and competencies up to date.
• Maintaining Client Relationships: Building positive relationships and providing guidance on medical device compliance.
• Co-Developing New Services: Contributing to the development of new certification services and participating in the company’s development projects.

Requirements

• Higher education in Electronics, Electrical Engineering, Automation, Medical Engineering, Biomechanics, or related fields.
• Minimum of 3 years of professional experience in the area of medical devices.
• Strong command of English - C1 .
• Excellent communication skills, with an ability to build relationships easily.
• Willingness to travel frequently, including internationally.
• Familiarity with quality management systems for medical devices, including knowledge of regulations such as MDD, MDR, IVDD, IVDR, and EN ISO 13485 is a plus.

Our Client Offers

• Work at one of our offices, with "home office" options available in other locations.
• Opportunities to utilize and further develop your professional qualifications.
• Collaboration with specialists in a friendly and cooperative atmosphere, including international work environments.
• A mobile role with travel opportunities, including international trips.
• A company car available for private use.
• Flexible working hours (start between 7:00 and 9:30 a.m.).
• Benefits package - private healthcare, co-funding for sports packages, accident insurance (NNW), and the option to join group insurance.
• Additional social benefits, including subsidies for vacations and tickets to cultural events.

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