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Quality Assurance Engineer Role Overview
This high-impact quality engineer position supports quality and process engineering activities across manufacturing and R&D, with a strong focus on CAPA investigations, technical documentation, and continuous improvement.
- Support cross-functional teams in implementing quality initiatives that drive business results
- Lead the development of technical documentation including FMEAs, Control Plans, protocols, and reports to ensure regulatory compliance
- Conduct root cause analysis and corrective actions to address non-conformances and reduce scrap
- Collaborate with engineers and QA stakeholders to execute continuous improvement projects that enhance product quality and efficiency
- Work autonomously to analyze data from production and quality systems to inform quality planning and risk management strategies
Requirements:
- 7 or higher qualification in Engineering, Science, or related discipline
- 4+ years' experience in senior QA or Quality Engineering role in regulated setting
- Proven track record of CAPA, technical writing, and project execution expertise
- Strong grasp of GMP and ISO quality systems
- Exposure to Six Sigma or Lean methodologies highly desirable
