Quality Assurance Associate
1 month ago
Thornhill Medical is a leading manufacturer of medical devices, dedicated to providing innovative solutions for emergency healthcare providers, humanitarian, and military medical teams. Our products are designed to be used globally, and our research and applications are transforming patient care in extreme circumstances.
Job SummaryThe Quality Assurance Associate is responsible for assisting in the daily operational management of Thornhill Medical's Quality System and ensuring compliance with all quality and regulatory requirements. This role involves managing and maintaining the Quality Management System, leading control of documents and Standard Operating Procedures, and reviewing and releasing documents and products.
Key Responsibilities- Manage and maintain the Quality Management System in compliance with ISO 13485 + MDSAP, CMDR, European MDD/MDR, and US FDA QSR country-specific requirements.
- Lead control of documents and Standard Operating Procedures within the Quality Management System.
- Review and release documents and products, ensuring compliance with quality and regulatory requirements.
- Assist in the development of technical documents, including incoming inspections.
- Provide multi-departmental support related to audits and inspections from regulatory agencies.
- Bachelor's degree or diploma in electrical or mechanical engineering or related field.
- Quality Assurance Manufacturing & Management Certificate would be an asset.
- 2-3 years of related experience in Mechanical or Electrical Engineering or in a manufacturing/production environment.
- Experience in quality management compliance at a medical device company with Class II and III devices is an asset.
- Knowledge of ISO 13485 + MDSAP, European MDD/MDR, and US FDA QSR requirements.
- Strong organizational skills with meticulous attention to detail.
- Strong analytical skills with experience interpreting quality data and presenting to management.
- Excellent problem-solving and troubleshooting skills.
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