QATechnician Markham, ON $58,000 - $65,000 a year Responsibilities:

• Work together with Quality team to establish the    quality control methodology and system    to ensure the high quality operations.
  
• Assist in the completion of ISO 13485 certification.
  
• Perform in process and final inspections and define appropriate    inspection and acceptance criteria.
  
• Plan and coordinate quality control    program designed to ensure continuous production of products consistent    with established standards
  
• Actively assure operational observance to compliance    obligations to include, regulatory, contractual, and SOP driven    requirements.
  
• Develop and initiate standards and methods for    inspection, testing, and evaluation.
  
• Monitor and maintain site Quality Metrics (includes    customer satisfaction interaction).
  
• Develop and review documentation for regulatory    appropriateness, correctness and organizational effectiveness.
  
• Apply total quality management tools and approaches to    analytical and reporting processes.
  
• Design and implement quality control training programs
  
• Ensure management and control of non-conforming    material/product process.
  

Preferred Qualifications:

• Proven track record with    implementation, maintenance of Quality Management Systems (ISO 13485).
  
• 1-3 years Quality Leadership experience in the medical    devices or pharmaceutical manufacturing industry
  
• Experience in a fast paced manufacturing environment is    preferred
  
• Knowledge of quality systems, ISO 13485, and regulatory    knowledge for medical devices and/or pharmaceutical manufacturing
  
• Proven track record with implementation, maintenance of    Quality Management Systems (i.e. ISO 9001, ISO 13485, ISO 22000, etc.) is    an asset
  
• Familiarity with federal regulations concerning    pharmaceutical products and/or medical device regulatory requirements
  
• Ability to evaluate scientific/technical information    from a Quality perspective.
  
• Knowledge and experience in risk management, tolerance    studies, product reliability and safety assessments
  
• Well-organized, multi-task oriented and efficient
  
• Effective communication skills
  
• High energy, self-motivated, and attention to detail
  
• Works well independently and as part of a team
  

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