Quality Specialist

1 month ago

North York, Canada Thornhill Medical Full time

ABOUT THORNHILL MEDICAL:


Thornhill Medical’s ground-breaking products are designed to be used globally by emergency health care providers, humanitarian, and military medical teams. Thornhill’s oxygen-focused research and applications are transforming patient care in extreme circumstances, while inspiring and enabling other new technologies to unlock vital life-saving solutions. Thornhill Medical’s innovations are in 19+ countries including Ukraine. With a team committed to courage, collaboration and saving lives, Thornhill Medical leads the way in the nimble and precision-focused field of medical technologies.


POSITION SUMMARY:

The Quality Specialist is responsible for leading and /or assisting in the daily operational management of the quality system in compliance with quality and regulatory requirements; designing and maintaining quality standards and processes; and determining corrective actions. The position works with various stakeholders to implement quality measures during design and in production. 


DUTIES & RESPONSIBILITIES:


  • Assists in the management and maintenance of the Quality Management System in compliance with ISO 13485 + MDSAP, CMDR, European MDD/MDR, US FDA QSR country specific requirements. 
  • Monitors, trends, and analyzes quality and product performance, and offer recommendations based on those analyses. Assists with any resulting health and hazard evaluation.  
  • Leads internal and supplier audits including creating audits plans, audit reports and closing out audit findings. 
  • Leads the material review board, assists with the investigation and troubleshooting of product and/or production issues. Reviews nonconforming product reports to ensure timely disposition of product. 
  • Provides Root Cause Analysis, leadership and assist other departments in the resolution of customer feedback, complaints, and service. 
  • Leads corrective actions, solutions, and improvements including coaching internal stakeholders to complete that. Maintains supplier quality agreements. Assists with quality input to supplier approval process. 
  • Maintains supplier quality agreements. Assists with quality input to supplier approval process.
  • Interfaces with Engineering and Operations to ensure design transfer process are in accordance with approved requirements. 
  • Responsible for certain KPIs and measures with regards to an improved product quality during development and production. 
  • Assists with the Regulatory Affairs maintenance and preparation for external regulatory audits.  
  • Coordinates the customer complaints process. 
  • Alerts management for all items affecting product quality/functionality in a negative manner. 
  • Conducts audits, including closing out audit findings, creating audits finding reports. 
  • Coaches, motivates, and communicates quality management focus cross-functionally to facilitate the achievement of quality deliverables. 
  • Collaborates with design teams and operations managers to develop and implement controls and improvements. 
  • Presents and/or chairs quality focused meetings and drive consensus/buy-in across multiple disciplines. 
  • Leads or supports continuous improvement projects, with a focus on quality and process improvements using problem solving methodologies such as: Kaizen, FMEA and Six Sigma. 
  • Considers quality in all aspects of the job and respects procedures and norms.  
  • Other duties as assigned. 

 


EDUCATION & EXPERIENCE:


  • Bachelor’s degree in engineering or science or related field. 
  • 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.
  • Experience in quality management compliance at a medical device company with HC Class II and III devices is an asset. 
  • Experience using quality systems. 


SKILLS & KNOWLEDGE:


  • Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives.
  • Ability to work under pressure at times managing a wide variety of activities.
  • 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.
  • Drive to consistently achieve results, even under tough circumstances.
  • Excellent problem solving and troubleshooting skills. 
  • Self-starter that is highly motivated, creative, and able to work both independently and within a team environment. 
  • Strong computer skills and proficient knowledge of Microsoft Suite (Word, Excel, PowerPoint).


OTHER REQUIREMENTS:


  • 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.


We thank all applicants for their interest, however, only those selected will be invited for an interview.


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