Hologic Looking for Quality Manager – Canada at Ontario 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

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