Quality & Compliance Specialist Accredited Laboratory & Standards Conformity

Our client is seeking a Quality & Compliance Specialist with strong expertise in standards conformity and laboratory-based testing within the medical device or electrotechnical domain. This role focuses on ensuring that products meet applicable regulatory and safety standards through close collaboration with accredited laboratories and adherence to established conformity assessment processes.

The ideal candidate combines a solid technical background with hands-on experience in compliance, testing coordination, and regulatory frameworks.

Key Responsibilities

• Ensure product compliance with applicable electrotechnical standards, particularly the IEC 60601 family for medical devices;
• Coordinate and manage conformity testing activities with accredited laboratories;
• Act as the main point of contact between internal teams and external testing partners;
• Support and oversee testing processes, including:
• Electrical safety testing
• Electromagnetic Compatibility (EMC)
• Radiation testing (if applicable);
• Review and interpret test reports to validate compliance with standards and regulatory requirements;
• Contribute to the preparation and maintenance of technical documentation and compliance files;
• Ensure alignment between product design, testing outcomes, and regulatory expectations;
• Maintain up-to-date knowledge of relevant standards and conformity assessment procedures;