Senior Quality Assurance Engineer Position
We are seeking an experienced Senior Quality Assurance Engineer to implement and promote best-in-class quality assurance throughout the product lifecycle for our client device.
The ideal candidate will have a minimum of 5 years' experience in quality management systems within the medical device industry, with excellent problem-solving skills and an innovative mindset to drive the implementation of advanced, efficient, and appropriate quality management practices.
Key Responsibilities:
* Ensure compliance with quality systems procedures, including ISO 13485 standards and 21 CFR Part 820 regulations.
* Champion continuous improvement and innovation in the quality system, developing and improving procedures and systems for efficient compliance.
* Lead and coordinate internal audits, ensuring they are completed on schedule.
* Interact with regulatory bodies, such as the FDA, and certification bodies in relation to QMS auditing, certification, and changes.
* Analyze quality system data for reporting across the organization.
* Manage complaint handling and corrective/preventive action processes.
Requirements:
* Degree in Quality Assurance, Quality Engineering, or similar qualification.
* Minimum 5 years' experience in a relevant role within the medical device industry.
* Broad experience in Medical Device Quality Management Systems, including electronic QMS systems.
* Experience in CAPA and complaint handling systems.
* Familiarity with ISO 13485 and 21 CFR Part 820 FDA requirements and managing regulatory body audits.