Quality Management Systems Specialist
Date: Aug 4, 2025
Location: Rochester, NY, US
Company: Carestream Health
Innovation that sparks imagination. Continue on to your next challenge with us.
Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications—all backed by a global service and support network. Carestream’s diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.
At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact. Join our global team of 3,000+ professionals!
Compensation: $78,000 - $100,000
*This range reflects Carestream’s good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate’s experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.
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.
Position Responsibilities:
• 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
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.)
Work Environment:
Office environment
Carestream is an Equal Opportunity Employer
Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Applying for a job with Carestream
All applicants must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations
Requisition ID: 4444
Nearest Major Market: Rochester