A Quality Assurance Manager is responsible for ensuring that the daily operations of manufacturing and production processes meet the required quality standards. It involves monitoring and improving the quality of products and processes within the organization. overseeing and enhancing the quality assurance processes within the manufacturing and production operations.

The QA Manager will lead the quality control team and oversee the quality issues raised as part of the operations and production. This role ensures compliance with regulatory standards, improves quality processes, and supports product manufacturing activities to maintain high- quality standards.

Reporting to the company’s QA & RA Director

Qualifications:

Experience

Minimum of 4-8 years of experience in quality assurance/ quality control within the medical device industry.

Experience with QMS implementation and maintenance, including ISO 13485 and FDA QSR requirements.

Proven track record in managing regulatory inspections and audits.

Skills

• • Strong knowledge of medical device regulations and standards (FDA, ISO 13485).
  • Excellent leadership and team management skills.
  • Strong analytical and problem- solving abilities.
  • Ability to work in a fast- paced and dynamic environment
  • Effective communication and interpersonal skills.
  • Proficiency in quality management software and tools.
  • Fluent in English.