Job Title: Senior Quality Assurance Specialist
As a senior quality assurance specialist, you will play a crucial role in supporting the development and implementation of quality processes that drive business growth and customer satisfaction. You will be responsible for owning and leading CAPA investigations, root cause analysis, and corrective actions to ensure compliance with regulatory requirements.
* Develop, update, and manage technical documentation, including FMEAs, control plans, protocols, and reports.
* Drive risk management processes and quality planning for product development, ensuring timely and cost-effective delivery.
* Collaborate with cross-functional stakeholders on continuous improvement projects, leveraging your analytical skills to identify areas for enhancement.
* Analyze data from production and quality systems to reduce scrap and address non-conformances, applying statistical methods to inform decision-making.
Key Responsibilities:
* Lead CAPA investigations, root cause analysis, and corrective actions to ensure compliance with regulatory requirements.
* Develop and implement quality plans to drive process improvements and customer satisfaction.
* Collaborate with cross-functional teams to drive business growth and customer satisfaction.
* Apply analytical skills to analyze data from production and quality systems to reduce scrap and address non-conformances.
Requirements:
* 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 CAPA, technical writing, and project execution.
* Strong grasp of GMP and ISO quality systems.
* Exposure to Six Sigma or Lean methodologies is highly desirable.
* Ability to influence, plan, and follow through on cross-functional projects.
Benefits:
* Opportunity to work in a dynamic and fast-paced environment.
* Collaborative and supportive team culture.
* Professional development opportunities.