Quality Control and Quality Specialist

Role & responsibilities

The QC & QA Specialist will oversee and ensure that all surgical products meet the highest quality standards and comply with industry regulations. This role involves monitoring production processes, conducting inspections, maintaining documentation, and implementing quality systems to enhance product safety and reliability.

Key Responsibilities:

Quality Control (QC)

• Conduct inspections of raw materials, in-process components, and finished surgical products to ensure adherence to specifications.
• Perform routine tests and measurements using precision instruments and equipment.
• Identify and document defects or non-conformities and work with production teams to implement corrective actions.
• Monitor calibration of testing equipment and tools to maintain accuracy and consistency.
• Maintain detailed records of inspections, testing results, and non-conformity reports.

Quality Assurance (QA)

• Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485 and other relevant standards.
• Review and approve production processes, work instructions, and quality control plans.
• Conduct internal audits to assess compliance with regulatory and organizational standards.
• Investigate customer complaints and product issues, ensuring effective root cause analysis and corrective/preventive actions (CAPA).
• Collaborate with cross-functional teams to train employees on quality procedures and ensure process adherence.
• Prepare and manage quality documentation, including SOPs, validation protocols, and technical reports.
• Support regulatory inspections and audits by providing documentation and expertise.

Qualifications and Skills:

• Education: BSC / MSC.
• Experience: Minimum 2 years of experience in quality control or quality assurance within a medical device or surgical manufacturing environment.