We are looking for Quality Engineers with 57 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.
