
Senior Technical Specialist
2 weeks ago
Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to support our quality projects. This is a hands-on role that involves working closely with cross-functional teams to drive quality initiatives and improve processes.
Key Responsibilities:- Support quality and process engineering activities in both manufacturing and R&D
- Own and lead investigations, root cause analysis, and corrective actions
- Develop, update, and manage technical documentation (FMEAs, Control Plans, protocols)
- Drive risk management processes and quality planning for product development
- Collaborate with engineers and stakeholders on continuous improvement projects
- Analyse data from production and quality systems to reduce scrap and address non-conformances
- Level 7 or higher qualification in Engineering, Science, or related discipline
- Minimum 4 years' experience in a senior QA or Quality Engineering role in a regulated setting
- Proven experience with technical writing and project execution
- Strong grasp of GMP and ISO 13485 quality systems
- Exposure to Six Sigma or Lean methodologies is highly desirable
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