Senior Validation, Quality Systems and Compliance Specialist
Cameleon RH•Thomson, GA
•Onsite
About The Position
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!
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
- Ability to travel domestically and internationally as required (less than 25% of the time)
Nice To Haves
- Master’s degree and/or professional certification in a scientific or engineering discipline
- French language capability (preferred but not required)
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
