Job Title: Quality Assurance Specialist
Key Responsibilities:
* Develop and implement quality control plans, processes, and procedures to ensure compliance with industry standards.
* Collaborate with cross-functional teams to identify and mitigate quality risks, ensuring alignment with business objectives.
* Conduct process failure mode effect analysis (PFMEA), risk assessments, and corrective action planning to drive continuous improvement.
* Implement and maintain quality management systems, ensuring adherence to regulatory requirements and internal policies.
* Investigate and resolve quality-related issues, providing actionable recommendations for process enhancements.
* Provide coaching and guidance to team members on quality principles, best practices, and regulatory requirements.
* Develop and deliver training programs to enhance quality awareness and skills among employees.
* Monitor and analyze quality metrics, identifying trends and areas for improvement.
Requirements:
* Bachelor's Degree in a relevant field such as Engineering, Science, or Quality Assurance.
* At least three years of experience in a quality assurance role within the medical device industry.
* Proven track record of implementing quality improvements, reducing defects, and enhancing customer satisfaction.