Senior Validation, Quality Systems and Compliance Specialist

Senior Validation, Quality Systems and Compliance Specialist Job Details

Location: On-site at UME, Thomson, United states

Employment Type: Full-time permanent position

You will contribute to a global organization within the medical device industry, supporting production and distribution operations across multiple sites, with a primary focus on the North American division.

You will collaborate with cross-functional stakeholders and leadership teams to drive standardization, efficiency, and compliance across Validation and Quality Systems and Compliance (QSC) functions.

This role operates within a strategic and operational environment where your expertise will directly influence quality management system (QMS) performance and regulatory compliance.

As a Senior Validation, Quality Systems and Compliance Specialist, you will act as a subject matter expert and play a key role in defining, implementing, and improving validation and QSC strategies.

• Act as a senior subject matter expert for Validation and QSC functions across Medicom divisions and sites, primarily in North America
• Implement centralized Validation, QSC and Quality Operations strategies and drive standardization of processes and best practices
• Collaborate with management on organizational planning, operating models, and governance procedures
• Facilitate compliant, efficient, and risk-based execution of QSC, Quality Operations, Design Quality and Supplier Quality processes
• Support validation activities including Computer Software Assurance Validation, Production Process Validation, monitoring and controls
• Contribute to CAPA, Design Transfer, Supplier Qualification and Monitoring, SCAR, documentation control, QMS training, and site QMS certification
• Support validation master planning and overall validation program compliance across sites
• Drive continuous improvement and standardization of QMS processes aligned with corporate strategy
• Ensure compliance with regulatory requirements including FDA QSR, ISO 13485, CDC NIOSH, and EU MDR
• Lead or support remediation activities related to quality systems or regulatory requirements

• Bachelor's degree in engineering, life sciences, quality/regulatory, or related technical discipline
• Minimum of 8 years of experience with increasing responsibility in regulatory, quality, or compliance within the medical device industry or equivalent

• Master’s degree and/or professional certification in a scientific or engineering discipline
• French language capability (preferred but not required)

• Ability to travel domestically and internationally as required (less than 25% of the time)