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    Quality & Regulations Associate - Richmond Hill, ON, Canada - Amico Group of Companies

    Amico Group of Companies
    Amico Group of Companies Richmond Hill, ON, Canada

    1 week ago

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    Description

    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.
    #J-18808-Ljbffr
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