Senior Validation, Quality Systems and Compliance Specialist

Cameleon RH • Pointe-Claire, QC

2d • Remote

About The Position

The candidate will be required to travel within North America up to 50% of the time. The incumbent acts as a senior subject matter expert in Validation and Quality Systems and Compliance (QSC), supporting and advancing Medicom’s overall Quality Management System (QMS) strategy. The role contributes to regulatory compliance, standardization, and operational efficiency across Medicom Group’s production and distribution operations, with a primary focus on the North American division (NAM) and limited consultative support to other Medicom divisions. The position is responsible for defining and driving the implementation of a centralized Validation and QSC strategy and roadmap, identifying applicable requirements for stakeholders across the organization, and exercising risk-based, critical-thinking leadership to ensure compliance with quality and regulatory requirements while supporting business objectives.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
• A minimum of 8 years of progressive experience with increasing responsibility in regulatory, quality, or compliance functions within a regulated medical device environment, or an equivalent regulated industry.

Nice To Haves

• Master’s degree and/or professional certification in a scientific, engineering, or related technical discipline.
• French language capability preferred but not required.

Responsibilities

• Implement direction and strategy of centralized Medicom Validation, QSC and Quality Operations functions.
• Consult with stakeholders to drive standardization of Validation and QSC processes and best practices across the Medicom group business.
• Collaborate with management in determining departmental organizational plan, operating model, strategy deployment and governance procedures.
• Facilitate compliant, efficient and risk-based execution of level 1 QSC, Quality Operations, Design Quality and Supplier Quality processes and level 2 Computer Software Assurance Validation, Production Process Validation, Production Process Monitoring and Controls, CAPA, Design Transfer, Supplier Qualification and Monitoring, SCAR, Documentation Control, QMS Training, and Site QMS Certification.
• Support achievement and improvement of validation master planning and overall validation program compliance as shared service for Medicom sites where historical validation status may not meet current internal standards.
• Drive QMS process development, continuous improvement and corporate QMS standardization outcomes to serve business objectives and global QMS CI program and roadmap.
• Facilitate validation, quality and regulatory compliance and collective business process development and improvement using CI philosophy and tools.
• Ensure QSC and QMS processes comply with applicable regulatory standard requirements including FDA QSR, ISO 13485, CDC NIOSH and EU MDR requirements.
• Lead or support efforts for quality system or regulatory requirement remediation activities if necessary.

Benefits

• Competitive salary.
• Comprehensive benefits package, including Employee Assistance Program (EAP) and telemedicine services.
• Company-matched retirement plan.
• Opportunities for training, coaching, and professional development.
• A dynamic and friendly work environment, with an active social committee organizing events such as sports activities, BBQs, and family gatherings.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior