Senior Validation, Quality Systems and Compliance Specialist

Senior Validation, Quality Systems and Compliance Specialist

Full time | Cameleon RH | United States

Georgia, Code postal 30824

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!

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

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

Nice to have:

• 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)