Job Title: Quality Assurance Specialist
Overview:
This position requires an experienced and proven track record in quality assurance and regulatory control of medical devices. The role will focus on ensuring product quality during early development phases through to commercial.
Responsibilities include developing and supporting quality management system activities, batch release, internal audits, and supplier management. Ensuring compliance with policies and procedures and applicable national and international regulations is a key aspect of this role.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.
* Provide expertise in the areas of quality assurance, controls, and systems to support and develop the company's quality management system.
* Develop and execute quality system audits, act as an audit escort, and support coordination of backroom activity during inspections as required.
* Collaborate with internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial.
* Ensure compliance with product specifications, regulations, and internal requirements by gathering and analyzing data to support statistical rational sample testing requirements during early product development.
Requirements:
- Bachelor's degree in engineering or a related technical field.
- Minimum of 3 years of experience in quality engineering within the medical device industry, preferably with neuro-interventional devices.
- Strong understanding of basic engineering principles.