Quality & Regulations Associate

2 months ago

Richmond Hill ON, Canada Amico Group of Companies Full time
Quality & Regulations Associate - Amico Clinical Solutions

Quality Assurance & Regulations Associate – Amico Clinical Solutions

Richmond Hill, ON

Would you like to work for a global company that is dedicated to personal career growth? Amico Corporation is a leading manufacturer of Medical Equipment with 9 manufacturing facilities employing over 1100 people across North America.

We are currently seeking a Quality & Regulations Associate to join our QC team

The Quality & Regulations Associate assists in ensuring that all processes and procedures are captured and comply with regulatory and accreditation standards.

Responsibilities:
  • Interpret and incorporate regulatory and accreditation requirements into new and existing procedures.
  • Ensure all processes and procedures are compliant with Health Canada Medical Device regulatory requirements.
  • Ensure all processes and procedures comply with all other accreditation requirements.
  • Assist in maintaining the Quality Management System.
  • Assist in maintaining the Quality Manual.
  • Ensure all non-conforming processes are captured and assessed using a risk-based approach, root-cause analysis and generate corrective and preventative actions.
  • Participate in internal and external audits.
  • Participate in regulatory/accreditation audits.
  • Continuously seek continuous improvement opportunities.
  • Ensure adherence to current processes and procedures as well as health and safety guidelines.
  • Provide training and assistance to all staff regarding process, procedures and QMS requirements.
  • Other duties as assigned by the Quality Assurance & Regulations Manager.

Quality Assurance & Regulations Associate – Amico Clinical Solutions

Richmond Hill, ON

Would you like to work for a global company that is dedicated to personal career growth? Amico Corporation is a leading manufacturer of Medical Equipment with 9 manufacturing facilities employing over 1100 people across North America.

We are currently seeking a Quality & Regulations Associate to join our QC team

The Quality & Regulations Associate assists in ensuring that all processes and procedures are captured and comply with regulatory and accreditation standards.

Responsibilities:
  • Interpret and incorporate regulatory and accreditation requirements into new and existing procedures.
  • Ensure all processes and procedures are compliant with Health Canada Medical Device regulatory requirements.
  • Ensure all processes and procedures comply with all other accreditation requirements.
  • Assist in maintaining the Quality Management System.
  • Assist in maintaining the Quality Manual.
  • Ensure all non-conforming processes are captured and assessed using a risk-based approach, root-cause analysis and generate corrective and preventative actions.
  • Participate in internal and external audits.
  • Participate in regulatory/accreditation audits.
  • Continuously seek continuous improvement opportunities.
  • Ensure adherence to current processes and procedures as well as health and safety guidelines.
  • Provide training and assistance to all staff regarding process, procedures and QMS requirements.
  • Other duties as assigned by the Quality Assurance & Regulations Manager.
Qualifications:
  • Experience with Health Canada, ISO, TUV SUD and UK MDR requirements.
  • Excellent written and verbal communication skills.
  • Excellent interpersonal skills.
  • Excellent problem-solving, analytical and decision-making skills.
  • Excellent attention to detail.
  • Excellent organizational, time management and multi-tasking skills.
Education and Experience:
  • 2+ years in Quality Assurance in similar field
  • Bachelors in a science related field
  • Certification in Lean Six Sigma
  • Certification in relevant Quality fields
For more information, please visit us at

*Only selected candidates will be contacted.
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