Job Description

  • Lead design quality assurance activities throughout the entire Product Development Lifecycle (PDLC).
  • Provide expert guidance to R&D teams on design controls, including design inputs, outputs, verification, and validation.
  • Oversee and manage the Quality Management System (QMS) processes specifically related to design and development.
  • Facilitate risk management activities, including FMEA (Failure Mode and Effects Analysis) and hazard analysis.
  • Manage and lead Corrective and Preventive Action (CAPA) and Non-Conformance Report (NCR) processes to ensure timely resolution of quality issues.
  • Ensure all technical documentation and Design History Files (DHF) are compliant with international regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820).

Job Requirements

  • Experience: Minimum of 5 years of experience in Design Quality or a similar R&D quality role within the medical device industry.
  • Technical Expertise: Strong working knowledge of QMS, CAPA, and NCR procedures.
  • Language Skills: Excellent command of English (both written and verbal) for collaboration with international stakeholders.
  • Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical field.