Spec Tech Quality Assurance

About the role

This position is responsible for executing and supporting product quality release activities for medical devices, implants, and instruments. The role ensures that all products meet regulatory, technical, and Quality Management System (QMS) requirements before they are released for distribution or use.

Key responsibilities

• Perform technical reviews of product release documentation to verify compliance with applicable regulations and internal standards.
• Ensure all release activities follow the company’s QMS procedures and are properly recorded.
• Coordinate with cross‑functional teams, including engineering, regulatory affairs, and manufacturing, to resolve any release issues.
• Maintain release records and support internal and external audits related to product quality.
• Assist in the preparation of release packages for orthopedic devices and related product lines.

Required profile

• Technical or engineering degree, or equivalent qualification in a related field.
• Experience in medical device quality release or a similar quality assurance role.
• Familiarity with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820.
• Strong attention to detail and ability to work collaboratively in a team environment.

Required skills

• Regulatory compliance knowledge (ISO 13485, FDA 21 CFR Part 820).