Product Quality Expert
We are seeking a highly experienced Product Quality Expert to drive excellence in product and process quality for medical devices.
Role Overview:
This key position is critical in ensuring compliance with global regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and MDR.
* Lead the development and implementation of quality management systems and processes.
* Conduct thorough investigations into non-conformances, CAPA, and complaints.
* Collaborate with cross-functional teams on design controls, risk management, and validation.
* Support internal and external audits and drive continuous improvement initiatives.
Requirements:
* Degree in Engineering, Science, or related field.
* Minimum 5 years' experience in quality within a medical device or regulated industry.
* Strong knowledge of regulatory standards, CAPA, and validation principles.
* Experience with Lean/Six Sigma tools; CQE or Green Belt certification a plus.
* Excellent problem-solving, communication, and interpersonal skills.