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)
Senior Validation, Quality Systems and Compliance Specialist in thomson at Unknown Company
This position is listed as full time and onsite.