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Quality Assurance Specialist
2 months ago
Thornhill Medical is a pioneering company that designs and manufactures innovative medical devices for emergency healthcare providers, humanitarian teams, and military medical units. Our products are transforming patient care in extreme circumstances and inspiring new technologies to unlock vital life-saving solutions.
Job SummaryThe Quality Control/Quality Assurance Associate plays a critical role in ensuring the daily operational management of Thornhill Medical's Quality System and ensuring compliance with all quality and regulatory requirements.
Key Responsibilities- Assist in managing and maintaining the Quality Management System in compliance with ISO MDSAP, CMDR, European MDD/MDR, and US FDA QSR country-specific requirements.
- Lead the control of documents and Standard Operating Procedures (SOPs) within the Quality Management System.
- Lead/support the review, control, and release of documents and keep records in support of the quality management system, including maintaining the design history file, device history records, and device master records.
- Control testing equipment process.
- Coordinate quality training process with other departments in the organization and ensure training records are compliant.
- Assist with releasing products by reviewing/inspecting quality records and products.
- Assist in the development of technical documents, including incoming inspections.
- Provide multi-departmental support related to audits and inspections from regulatory agencies (e.g., Health Canada, FDA, European).
- 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.
- Experience using quality systems.
- Knowledge of ISO MDSAP, European MDD/MDR, 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.
- Strong time management skills.
- Self-starter that is highly motivated, creative, and able to work both independently and within a team environment.
- Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives.
- Excellent interpersonal and communication skills (verbal and written).
- Drive to consistently achieve results, even under tough circumstances.
- Holds self and others accountable to meet commitments.
- Strong computer skills and proficiency with Microsoft Office suite products (Word, Excel, PowerPoint).
Primarily office environment with exposure to production work rooms when required. Light lifting and bending. Some travel required.
Thornhill Medical welcomes and encourages applications from all qualified people, including those with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
