Job Title

We are looking for Quality Engineers with 5–7 years of experience to support quality and compliance activities for Medical devices domain on a 1-year contract. Job Description:Develop, implement, and maintain quality systems in accordance with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.Support design control activities, including risk management, verification/validation, and design transfer.Conduct root cause analysis and corrective/preventive actions (CAPA).Collaborate with cross-functional teams (R&D, Regulatory Affairs, Manufacturing, Supply Chain) to ensure quality throughout the product lifecycle.Perform supplier quality audits and manage supplier qualification processes.Review and approve validation protocols, reports, and test methods.Ensure compliance with Good Manufacturing Practices (GMP) and applicable standards.Support internal and external audits, inspections, and regulatory submissions.Drive continuous improvement initiatives in quality processes and systems.Qualifications:Bachelor’s degree in engineering, Life Sciences, or related field.5 - 7 years of experience in quality engineering within medical devices or other regulated industries.Strong knowledge of ISO 13485, FDA QSR, EU MDR, and risk management standards (ISO 14971).Experience with CAPA, nonconformance handling, and root cause analysis tools (e.g., FMEA, 5-Why, Fishbone).Familiarity with validation processes (IQ/OQ/PQ) and statistical techniques.Excellent communication, documentation, and problem-solving skills.Ability to work independently and in cross-functional teams.Preferred Skills:Experience with software validation and electronic quality management systems (eQMS).Knowledge of Six Sigma or Lean methodologies.Prior involvement in new product development projects.Audit certification (e.g., ISO 13485 Lead Auditor) is a plus.