Senior Complaint - Mississauga - Fuze HR Solutions

    Fuze HR Solutions
    Fuze HR Solutions Mississauga

    3 days ago

    Description

    Join to apply for the Senior Complaint & Quality Specialist role at Fuze HR Solutions.

    Contract Type: 2-year contract (Temporary or Incorporated)

    Role Summary

    The Lead Investigator will oversee product complaint investigations and trend analyses for medical devices, combination products, and drug delivery systems. This role supports both clinical trials and commercial products, playing a crucial part in identifying product quality issues, evaluating trends, and implementing corrective and preventive actions to maintain consistent product and manufacturing quality.

    Primary Responsibilities

    • Lead investigations for both critical and non-critical product complaints with limited supervision.
    • Develop investigation plans and ensure reports are thorough, accurate, and compliant with company and regulatory standards.
    • Handle global complaints related to products that are manufactured, packaged, labeled, or distributed through clinical and commercial supply chains.
    • Initiate, review, approve, and close complaint records in the Quality Management System (including Complaints, Deviations, CAPAs, etc.).
    • Evaluate potential failure modes and risk impacts to determine root causes.
    • Draft, review, and approve CAPAs, ensuring timely resolution of quality issues.

    Cross-Functional Collaboration & Leadership

    • Collaborate with global teams across Manufacturing, Packaging, Device Quality, Supply Chain, and Affiliates to drive efficient investigations.
    • Lead root cause analysis sessions and present findings at Quality Review Boards (QRBs).
    • Act as the Quality representative on cross-functional and multi-site initiatives.
    • Provide mentorship and training on complaint management and quality processes.

    Trend Analysis & Continuous Improvement

    • Analyze complaint data to detect trends, emerging risks, and potential reporting or recall requirements.
    • Develop and maintain risk metrics and CAPA trend analyses for management review.
    • Identify opportunities to enhance complaint and quality system processes.
    • Assist with audits, regulatory inspections, and quality reporting tasks.

    Additional Duties

    • Communicate with patients and healthcare professionals as necessary.
    • Support quality system initiatives, including batch record reviews and continuous improvement projects.
    • Monitor complaint activity and elevate urgent issues to management.

    Education & Experience

    • Bachelor's degree (or higher), ideally in Life Sciences.
    • 8+ years of experience in pharmaceutical, biopharmaceutical, or medical device environments.
    • Strong technical writing abilities.
    • Deep understanding of medical devices, combination products, and drug delivery systems.
    • Experience with drug substance and drug product manufacturing processes (small and large molecules).
    • Proficiency with quality tools such as Six Sigma / DMAIC.
    • Experience working in global, matrixed organizations.
    • Familiarity with enterprise quality systems, collaboration platforms, and analytics tools.
    • Thorough knowledge of GMP, Quality Systems, global regulatory standards, and Health Authority expectations.
    • Proven experience managing complaints, investigations, CAPAs, and sample reconciliation.
    • Strong analytical, statistical, and critical-thinking skills.
    • Clear and professional written and verbal communication; fluent in English.
    • Ability to collaborate and influence without formal authority.
    • Strong stakeholder management skills and relationship-building across global teams.
    • Continuous improvement mindset with Lean and Agile approaches.
    • Proactive, accountable, and comfortable working independently on complex challenges.
    • Additional language skills are an advantage.

    Seniority level


    Mid-Senior level

    Employment type


    Full-time

    Job function


    Quality Assurance

    Industries


    Medical Equipment Manufacturing and Pharmaceutical Manufacturing

    Referrals increase your chances of interviewing at Fuze HR Solutions by 2x

    Get notified about new Complaints Handler jobs in Mississauga, Ontario, Canada.


    #J-18808-Ljbffr

  • Senior Complaint

    1 month ago

    Only for registered members Mississauga, Ontario

    The Lead Investigator will oversee product complaint investigations and trend analyses for medical devices, combination products, and drug delivery systems. · ...

  • Senior Complaint

    1 month ago

    Only for registered members Mississauga

    The Lead Investigator will oversee product complaint investigations and trend analyses for medical devices, combination products, and drug delivery systems. · Complaint Investigations & Quality Management · Lead investigations for both critical and non-critical product complaints ...

  • Senior Compliance Officer, Complaints

    1 month ago

    Only for registered members Toronto $75,900 - $141,900 (CAD)

    Assists in the implementation, maintenance and administration of an enterprise compliance program with a special focus on complaints, sales practices and distribution channels. · ...

  • Senior Compliance Officer, Complaints

    1 month ago

    Only for registered members Toronto Full time $75,900 - $141,900 (CAD)

    Assists in the implementation, maintenance and administration of an enterprise compliance program (regulatory compliance) with a special focus on complaints, sales practices and distribution channels. · ...

  • Senior Compliance Officer, Complaints

    1 month ago

    Only for registered members Toronto, Ontario

    Assists in the implementation, maintenance and administration of an enterprise compliance program (regulatory compliance) with a special focus on complaints, sales practices and distribution channels. · ...

  • Senior Compliance Officer, Complaints

    1 month ago

    Only for registered members Toronto, ON MX C

    Assists in the implementation maintenance and administration of an enterprise compliance program with a special focus on complaints sales practices and distribution channels. · Provides advice guidance to assigned business group on implementation of solutions aligned to regulator ...

  • Senior Compliance Manager, Complaints, Reporting

    6 days ago

    Only for registered members Toronto $94,600 - $176,000 (CAD)

    You will have the opportunity to lead a team of high-performing compliance professionals to deliver fair and timely client resolutions while upholding regulatory expectations and building client trust. · ...

  • Manager, Support Services

    1 week ago

    Only for registered members Mississauga, ON

    We are looking for a motivated and organized Manager to lead and coordinate administrative and operational support functions within our organization. · We are seeking a highly motivated individual who thrives in a fast-paced environment · Demonstrates strong communication and lea ...

  • Manager, Support Services

    1 month ago

    Only for registered members Mississauga, ON

    We are looking for a motivated and organized Manager to lead administrative and operational support functions within our organization. This role is responsible for planning and overseeing daily operations. · Tasks · Co-ordinate administrative services · Manage the operations of a ...

  • Director, Clinical

    1 month ago

    Only for registered members Mississauga, Ontario

    The Director, Clinical is responsible for providing leadership and strategic direction on clinical services while ensuring compliance · with professional practice standards across departments within the clinical organization. · The incumbent must have a BScN degree along with 8-1 ...

  • Senior Logistics Coordinator

    1 month ago

    Only for registered members Mississauga, Ontario

    We are seeking Senior Logistics Coordinators to enhance our dynamic team in the Toronto office. · This role is pivotal for those who excel in navigating the complexities of logistics with a forward-thinking approach. · The ideal candidate will bring a proactive mindset to foresee ...

  • Logistics Coordinator

    4 weeks ago

    Only for registered members Mississauga, Ontario

    We are seeking Senior Logistics Coordinators to enhance our dynamic team in the Toronto office. · ...

  • Director, Clinical Services

    1 week ago

    Only for registered members Mississauga, Ontario

    The Director Clinical Services is responsible for providing leadership and strategic direction on clinical services while ensuring compliance professional practice standards and professional development across departments within clinical organization. · ...

  • Customer Care Officer

    4 weeks ago

    Only for registered members Mississauga, Ontario

    Senior Customer Care Officer will respond with professional and expert service for all client concerns and escalations on behalf of RBC Life. · Proven experience in Life & Health · ...

  • Regional Manager

    1 hour ago

    Only for registered members Mississauga, ON

    The Regional Dental Manager oversees multiple dental clinics in a region ensuring high-quality patient care and compliance with regulatory standards. · ...

  • Quality Assurance Specialist

    1 month ago

    Only for registered members Mississauga, Ontario

    Cardinal Health Canada is seeking a Quality Assurance Specialist to join their Regulatory Affairs and Quality Assurance team. · This role involves developing and implementing quality policies, procedures, and processes to ensure products comply with regulatory standards. · The s ...

  • human resources generalist

    2 weeks ago

    Only for registered members Mississauga, Ontario

    The human resources generalist will administer staff consultation and grievance procedures. They will review HR projects to ensure compliance with laws and regulations. They will advise managers and employees on the interpretation of human resources policies, benefit programs and ...

  • Senior Chemist

    1 day ago

    Only for registered members Mississauga, Ontario, Canada

    We have current openings for a Senior Chemist to join our growing team in Mississauga. · ...

  • human resources generalist

    3 weeks ago

    Only for registered members Mississauga, Ontario

    Plan, develop and implement human resources policies and programs. · ...

  • Specialty Programs

    4 weeks ago

    Only for registered members Mississauga, Ontario

    We're innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we're caring and supporting our customers in new ways every day. · Innovate Health & Wellness · ...

  • Manager Customer Experience

    1 month ago

    Only for registered members Mississauga, Ontario

    L'objectif principal est de créer une expérience client mémorable pour les clients de TD Canada Trust en leur fournissant une assistance personnalisée pour leurs besoins financiers. · Mentor un équipe en mettant en avant des expériences exceptionnelles dans chaque interaction ave ...

Jobs
>
Mississauga