Quality Manager

4 days ago

Toronto, Ontario, Canada Hologic Full time

Quality Manager - Canada

Toronto, ON, Canada

Develop, implement and manage Quality processes, quality system supporting company's strategy in Canada and ensuring that local MDEL regulations/requirements and corporate quality guidelines are being followed. Manage PMS activities and implement/maintain GDP for Hologic's supply chain organization in Canada.

FUNCTION ROLES AND RESPONSIBILITIES

Quality Management System:

  • Enhance and sustain Quality System in Canada, aligned with local current regulations, with corporate policies and with business strategy.
  • Manage the site Quality System.
  • Support and able to execute internal audits.
  • Identify necessary improvements, through KPI's analysis, and ensure their implementation in the regional Quality System processes (continuous improvement).
  • Analyze and manage risks identified through the Quality System, together with local management, addressing the implementation and of mitigation actions.
  • Establish Quality Agreements with local and international suppliers, ensuring their obligation to comply with local and corporate requirements, currently applicable.
  • Represent the company in interactions with local Health Authorities, Certification entities/companies and trade associations forums.
  • Disseminate and support the Quality Policy, mission and values, defined by the company, aligning that with other collaborators and contractors/suppliers.
  • Share with International RAQA leadership local plans/goals, challenges and achievements.
  • Support Global initiatives, evaluating the impact on QA areas and ensuring local necessary adjusts to them.
  • Identify the impact of new regulations, addressing required adaptations and communicating to local management and RAQA leadership.

Supply Chain Quality:

  • Implement all GDP (Good Distribution Practices) to all supply chain of all Hologic and third party products within Canada.
  • Supports the delivery of system solutions by assuring activities are conducted in a compliant but cost effective manner. Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations
  • Develop and manage supply chain quality KPI's for the corporate metrics
  • Check inbound shipments on damage and T control
  • Check RMA (returned material) inbound on quality matters
  • Help 3PL in remediation actions like re-pack
  • Create and follow up on NCEs and follow-up on QA KPIs
  • Create and maintain QA agreement
  • Have regular meetings with 3PL QA; liaison with Hologic QMS
  • Maintain quarantine actions

Post Market Surveillance:

  • Responsible that all complaints are handled according to the applicable procedures and regulations.
  • Responsible for timely submission of vigilance reports and any communication with Health Canada
  • Generation of PMS related KPIs and reports for senior management.
  • Responsible for regular and timely communication of PMS data and/or trend analyses throughout the EMEAC organization.
  • Maintain profound Canadian PMS knowledge and update internal Procedures and QMS as applicable.
  • Provide real-time support of the Post Market process during internal and external audits.

REQUIRED EDUCATION

  • Graduated in a discipline related to the required skills to execute the function.
  • Desirable a post-graduation in the area.

REQUIRED EXPERIENCE

  • Knowledge typically acquired during a minimum of 8 years' experience in the Medical Devices and IVD industries segment, with at least 6 years in a regulatory and quality role, in Canada.
  • QA Manager experience desirable.
  • Sound knowledge related to MDEL license in Canada
  • Vigilance reporting to Health Canada
  • Sound knowledge on Good Distribution Practices

REQUIRED QUALIFICATION

  • Knowledge of regulatory and quality requirements/regulations and standards.
  • Fluency in English, written and oral – speaking and understanding French is a plus
  • Intermediate knowledge of Office System tools.

REQUIRED COMPETENCES/SKILLS

  • Strong comprehension and experience in Quality Management System field.
  • Strong capability in problem resolutions.
  • Excellent multi-task/projects management, with little/no supervision.
  • Ability and experience with people management.
  • Capable of leading, managing, develop and motivate teams.
  • Ability to manage conflicts and delicated situations
  • Excellent oral and written communication.
  • Available for occasional national and international travels

#LI-Lb2


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