Quality Engineer Assistant

About the role

The Quality Engineer Assistant supports the Quality, Engineering, Production and Administrative teams in a medical device manufacturing environment. Working Monday to Friday, the role ensures that quality standards, regulatory requirements and customer expectations are met for Class I, II and III devices.

Key responsibilities

• Collect and provide engineering data required for quality assurance and product development.
• Prepare and translate technical documents, create component specifications and item master records.
• Draft and execute Validation of Test Methods (TMV) protocols under the guidance of a Quality Engineer.
• Support FMEA and risk analysis activities during production processes.
• Assist in new product development, supplier quality management and compliance documentation.
• Gather data for investigations of complaints, non‑conformances (NC) or CAPA actions.
• Maintain GMP‑compliant records, perform inventory tasks and keep the work area organized.

Required profile

• Strong attention to detail and ability to follow SOPs and GMP guidelines.
• Good organizational skills and ability to maintain accurate documentation.
• Willingness to work onsite in Heredia with occasional remote tasks as needed.

Required skills

• FMEA (Failure Mode and Effects Analysis)
• Validation of Test Methods (TMV) protocol development
• Document control and translation
• Good Manufacturing Practices (GMP) compliance