POSITION SUMMARY:

Assure compliance with global quality management system (QMS) regulation requirements including, but not limited to, the FDA’s Quality System Regulations (21 CFR 820), ISO 13485, ISO 9001, the EU Medical Devices Directive (MDD)/Regulations (MDR) and the 5 jurisdictions for MDSAP (Canada, Brazil, Japan, Australia, and US). Ensure that mandated processes are created, implemented and compliant across Carestream Health and internal/external business entities.

REQUIRED SKILLS & EDUCATION:

Education and Experience

• A BS in science or other technical discipline or 3+ years of directly relevant experience in the medical device or pharmaceutical industry.
• Experience with audit process (internal/external)

Key/Critical Competencies

• Knowledge of quality system standards and regulations: FDA QSR, ISO-9001 and ISO-13485 standards, MDD/MDR, jurisdictional requirements for MDSAP etc.
• Excellent written, oral and interpersonal communication skills with the ability to work in cross-functional teams at all levels of the organization.
• Creativity for identifying best practices and developing a plan to implement globally
• Ability to think clearly, analyze processes and provide solutions.
• Ability to handle simultaneous tasks and prioritize accordingly.
• Exhibits a high degree of integrity, initiative and motivation.
• Knowledgeable in MasterControl tools (ie. Document Control, Complaint Handling, CAPA, etc.)

• Review procedures, processes and organizations for compliance with GMP, FDA (21 CFR 820), ISO 13485, MDSAP, ISO 9001, MDD/MDR, CMDCAS, etc. standards and regulations.
• Support GMP and MDSAP, ISO audits (both internal and external) for Carestream Health organizations.
• Support Quality Management Reviews for Carestream Health organizations.
• Provide oversight and monitoring of investigations, corrective and preventive actions resulting from audits (internal/external) and Management Reviews
• Work with Quality Systems Director to develop and implement best practices for regulatory and standards compliance globally.
• Escort internal ISO/MDSAP/FDA auditors while on-site as applicable
• Supports the collection and reporting of applicable Quality System Metrics
• Become primary backup for the RA Document Control Administrator
• Works with RA Document Control Administrator and other Carestream Site Document Control Administrators to resolve non-compliant document control practices globally for Carestream