Senior Validation, Quality Systems and Compliance Specialist

Job Description
Senior Validation, Quality Systems and Compliance Specialist
Introduction

At Caméléon, we believe that happiness at work comes from the right match between the right role, the right company, the right manager, and a stimulating environment where you can thrive.

Today, we are offering an exciting opportunity to join a well-established company in the medical device industry, where quality, innovation, and patient safety are at the heart of everything they do.

If you are passionate about quality, detail-oriented, and enjoy understanding, analyzing, and improving processes, this opportunity could be exactly what you are looking for!

Job Details

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

Employment Type: Full-time permanent position

Work Environment

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.

Your Day-to-Day Role

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.

More specifically, you will:

• 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

The Must-Haves

• 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

Nice to have:

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

Other Requirements

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

6 Great Reasons to Apply!

• Take on a senior strategic role in validation and quality systems
• Contribute to global QMS standardization and compliance initiatives
• Work across multiple sites and divisions within a regulated industry
• Influence continuous improvement and operational excellence
• Collaborate with cross-functional teams and leadership
• Be part of a structured and compliance-driven environment

Ready to Join the Adventure?

We can't wait to meet you!

Send us your application today or reach out confidentially. At Caméléon, we are always looking for passionate talents ready to make a difference