About this opportunity
CameleonHR lists this Senior Validation, Quality Systems and Compliance Specialist opportunity in thomson, Georgia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Validation, Quality Systems and Compliance Specialist
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.
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)
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Worksite address
thomson, GA, 30824, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.