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Quality Assurance Specialist

2 months ago

Richmond Hill, Ontario, Canada Thornhill Medical Full time
About Thornhill Medical

Thornhill Medical is a pioneering medical technology company that designs and manufactures innovative products for emergency healthcare providers, humanitarian, and military medical teams. Our mission is to transform patient care in extreme circumstances and inspire new technologies to unlock vital life-saving solutions.

Job Summary

The Quality Assurance Specialist is a critical role that leads and/or assists in the daily operational management of the quality system in compliance with quality and regulatory requirements. This position is responsible for designing and maintaining quality standards and processes, determining corrective actions, and working with various stakeholders to implement quality measures during design and in production.

Key Responsibilities
  • Quality Management System: Assist in the management and maintenance of the Quality Management System in compliance with ISO 13485 + MDSAP, European MDD/MDR, US FDA QSR country-specific requirements.
  • Quality Analysis: Monitor, trend, and analyze quality and product performance, and offer recommendations based on those analyses. Assist with any resulting health and hazard evaluation.
  • Audits and Investigations: Lead internal and supplier audits, including creating audit plans, audit reports, and closing out audit findings. Lead the material review board, assist with the investigation and troubleshooting of product and/or production issues, and review nonconforming product reports to ensure timely disposition of product.
  • Corrective Actions: Lead corrective actions, solutions, and improvements, including coaching internal stakeholders to complete that. Maintain supplier quality agreements and assist with quality input to supplier approval process.
  • Regulatory Compliance: Assist with the Regulatory Affairs maintenance and preparation for external regulatory audits.
  • Customer Complaints: Coordinate the customer complaints process and alert management for all items affecting product quality/functionality in a negative manner.
  • Continuous Improvement: Conduct audits, including closing out audit findings, creating audit finding reports. Coach, motivate, and communicate quality management focus cross-functionally to facilitate the achievement of quality deliverables. Collaborate with design teams and operations managers to develop and implement controls and improvements.
  • Quality Leadership: Present and/or chair quality-focused meetings and drive consensus/buy-in across multiple disciplines. Lead or support continuous improvement projects, with a focus on quality and process improvements using problem-solving methodologies such as Kaizen, FMEA, and Six Sigma.
Requirements
  • Education: Bachelor's degree in engineering or science or related field.
  • Experience: 3-5 years of related experience in Mechanical or Electrical Engineering or in a manufacturing/production environment. 2 years of experience with ISO 13485 + MDSAP, European MDD/MDR, US FDA QSR requirements.
  • Skills and Knowledge: Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives. Meticulous and detail-oriented. Excellent interpersonal and communication skills (verbal and written). Strong time management and organizational skills. Strong analytical skills with experience interpreting quality data and presenting to management.
About Us

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.