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Senior Quality Engineer
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Tommy McKeown
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Contract
Senior Quality Engineer – 12 month Fixed Term contract
Job Summary:
We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contact. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 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.
Key Responsibilities:
Required:
Job Summary:
We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contact. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 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.
Key Responsibilities:
- 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
Required:
- 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.
- 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.
- 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.
- Self-motivated with a continuous improvement mindset.
