Quality Engineer
Quality Enginner (Freelance)
Location: Montpellier, France (hybrid)
Type: Freelance, full-time
Start Date: ASAP
Key Responsibilities
- Review and assess validation, change control, risk analysis (e.g., FMEAs), software validation, and microbiological/sterilisation documentation.
- Support product development, new product introduction, and sustaining engineering activities through all stages of the lifecycle, including design controls and process validation.
- Partner with manufacturing and quality teams to ensure effective incoming, in-process, and final inspection processes.
- Lead CAPA activities and manage nonconformance investigations to ensure timely and effective resolution of quality issues.
- Support field-related quality activities, including assessments, investigations, and corrective actions.
- Participate in internal and external audits, representing the quality function and ensuring organisational readiness.
- Analyse quality metrics and performance data to identify trends, mitigate risks, and drive continuous improvement.
- Initiate and deliver improvement initiatives while mentoring junior team members and supporting team coordination.
Qualifications & Experience
- Degree in engineering, science, or a related technical discipline, with at least 3 years' relevant industry experience.
- Strong knowledge of regulatory requirements and standards (e.g., ISO, EU MDR, FDA).
- Proven experience in validation activities, including design, process, and software validation.
- Competency in statistical analysis and data-driven decision-making; additional quality or risk qualifications are advantageous.
- Strong communication skills, attention to detail, and ability to make independent, risk-based decisions in a regulated environment.
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