Senior Quality Engineer

We are seeking a proactive and detail‑oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contract. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO and the fully implemented EU MDR.

Your responsibilities will include completion of end‑to‑end validation lifecycle (IQ/OQ/PQ), performing rigorous risk assessments (pFMEAs), and supporting the change control process to maintain product integrity. In addition, you will be a primary Quality Liaison for the production floor, supporting and driving root‑cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection.

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• Product and Process Validation: develop, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes to ensure high‑degree assurance of product requirements.
  
• Risk Management: lead and maintain risk management files, including pFMEAs ensuring that all potential failure modes are identified and mitigated.
  
• Production Quality Support: provide real‑time QA support to the operations team to address non‑conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions).
  
• Audit Readiness: support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements.
  
• Statistical Analysis: apply statistical techniques and tools (e.g., Minitab) to analyze process data, identify trends, and support data‑driven decision‑making for process improvements.
  
• Other duties as assigned.
  

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• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences.
  
• 5+ years of experience in quality assurance or Validation in the medical device or a similarly regulated industry.
  
• Solid understanding of ISO 13485, EU MDR, ISO 14971 and relevant medical device regulations.
  
• Strong analytical and problem‑solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
  
• Excellent written and verbal communication skills, especially in technical writing and documentation.
  
• Proficient in data analysis tools such as Excel, Minitab, Power BI or similar.
  

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• Certified Quality Engineer (ASQ CQE) or similar professional certification.
  
• Certified Internal or Lead Auditor.
  
• Knowledge of EU MDR and international medical device regulations.
  
• Six Sigma or Lean Certification is a plus.
  

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• Strong attention to detail and commitment to quality.
  
• Ability to manage multiple tasks and projects in a fast‑paced environment.
  
• Collaborative mindset with ability to work effectively across departments. xcfaprz
  
• Self‑motivated with a continuous improvement mindset.