Job Title: Product Quality Assurance Specialist
The primary function of this position is to ensure product quality through the implementation and maintenance of a robust Quality Management System (QMS). This includes ensuring compliance with regulatory requirements, developing and implementing control plans, inspection plans, and testing strategies. The specialist will work closely with suppliers to establish and maintain robust quality agreements.
Responsibilities:
- Develop, implement, and maintain QMS policies and procedures to ensure compliance with regulatory requirements.
- Conduct audits and assessments to evaluate the effectiveness of the QMS and identify areas for improvement.
- Collaborate with cross-functional teams to develop and implement corrective actions to address non-conformities and improve overall product quality.
- Work closely with suppliers to establish and maintain robust quality agreements, including periodic review of their quality metrics.
- Provide expertise in the areas of quality assurance, controls, and systems to support the development of the company's QMS.
Requirements:
- Bachelor's degree in engineering or a related technical field.
- Minimum of 3 years of experience in quality assurance within the medical device industry, preferably with neuro interventional devices.
- Strong understanding of basic engineering principles and quality management systems.