ISO 13485 Quality Assurance (QA) Specialist

Every role at CTK makes an impact on improving global health! As you bring your talent to the global market, you will make a positive impact on global healthcare by supporting an array of diagnostic products.

This position reports directly to QA Manager and the Management Representative. The ISO 13485 QA Specialist will be responsible for ensuring compliance with quality standards and regulations, primarily focusing on the ISO 13485 standard. The QA Specialist will support the development, implementation, and maintenance of quality management systems, procedures, and policies, and will provide guidance to employees on compliance issues. The ISO 13485 QA Specialist will also oversee internal audits, coordinate external audits, and manage non-conformances and corrective and preventive actions.

Maintain quality management systems that meet the requirements of ISO 13485 and other relevant regulations
Work with QA team, oversee internal audits to assess compliance with quality management systems, and identify areas for improvement
Manage non-conformances and corrective and preventive actions, ensuring timely and effective implementation of solutions
Coordinate and prepare for external audits, including regulatory agency inspections and customer audits
Guide employees on compliance issues, and ensure understanding of quality policies and procedures
Monitor and analyze quality metrics, and implement process improvements where necessary
Review and approve documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records
Participate in the development and implementation of training programs for quality management systems
Keep up-to-date with changes in regulations and standards related to ISO 13485, and ensure compliance

Bachelor’s degree in a scientific or technical discipline or equivalent experience
Minimum of 3 years of experience in quality assurance, with at least 1 year in IVD or medical device industry
Strong knowledge of ISO 13485 requirements and other relevant regulations and standards

Experience conducting internal and external audits, and managing non-conformances and corrective and preventive actions
Strong analytical, problem-solving, and organizational skills
Excellent communication and interpersonal skills, with the ability to influence and persuade stakeholders
Detail-oriented, with a focus on accuracy and quality
Ability to work independently, as well as part of a team
Proficiency in Microsoft Office applications and database software

Please send your resume to Leona: levaristo@ctkbiotech.com

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