Sr Qrc Medical Device Safety Specialist (Indiana-Hybrid)

The Senior QRC Medical Device Safety Specialist is primarily responsible to serve as a leader for the development, implementation and continuous improvement of regulatory and Medical Device Safety initiatives related to CE Operations Service.A This role is responsible for the synthesis, analysis, evaluation, and management of alerts, recalls, radiation dose badge program and Medical Device Safety related incidents. AThis role leads strategy and reporting to promote a culture of safety throughout TRIMEDX and for our customers.A

Location: Indianapolis, Indiana; we are seeking candidates in the central Indiana region; candidates must reside within a 70 mile range of Indianapolis. Our Central (Corporate) Office is located on the northwest side of Indianapolis. Position is a hybrid (a mix of remote & in-office, as well as travel). Hybrid schedule will be approximately 1-4 days in the office per month (and/or as necessary), the remainder remote & work travel.

ResponsibilitiesAAAAAAAAAA

• Provides expertise and guidance in interpreting policies, regulatory, accreditation, and/or governmental regulations, and ISO standards to assure compliance
  • ISO 13485 and 27001
  • Federal (FDA, CLIA, CMS)
  • State (s) (Department of Health and Human Services)
• Accreditations:
• Hospitals (TJC, HFAP, DNV)
• Ambulatory Surgery Centers (AAAHC, AAAASF, TJC)
• Modality (Laboratory - CAP, AABB; Imaging - ACR, NRC)
• Calibration (NIST, ACLASS, A2LA)
• Safety (Radiation, Laser, NIST, ANSI, NFPA, OSHA, Life Safety)
• All other regulations and standards as applicable
• Provide education and support for the overall QMS to ensure TRIMEDX maintains compliancy to applicable quality and regulatory standards in effort to mitigate patient safety risk (for external customers and internal stakeholders)
• Serves as a Subject Matter Expert related to Patient Safety staff, as well as to personnel in areas outside of Patient Safety, with a deep understanding of FDA regulations, federal, state, and accreditation requirements
• Leads and conducts a wide range of multifaceted scope and complex project activities on an individual or cross-functional project related basis, working within established timeframes, ensuring compliance with federal, state and accreditation requirements, as well as policies, procedures and guidelines
• Leads and is accountable for TRIMEDX Medical Device Safety reporting and vendor collaboration
• Oversees and maintains tracking of Medical Device Safety incident investigation escalations
• Participates and serves as the TRIMEDX liaison in patient and radiation safety committee meetings with external customers and vendors, related to alerts, recalls, radiation safety and potential Device Safety incidents
• Collaborates with cross-functional areas along with customers (internal and external), vendors, and subcontractor representatives to ensure QMS requirements are met, while fostering an environment of patient safety and high reliability
• Leads and manages remediation and monitoring related to alerts, recalls and potential Medical Device incident activities and closure of loop
• Creates, maintains, tracks, and provides reports of Medical Device Safety data in usable and actionable formats on a regular cadence
• Supports and maintains mechanisms for internal communications of Medical Device Safety related information (QRC Spotlight, Marketing ConXion, etc.)
• Assists with verbal and written communications with customers, vendors, and other healthcare professionals in response to Medical Device Safety events, quality measures, etc.
• Provides administrative support of radiation dose badge program

Skills and Experience

• Experience reading and interpreting technical documents such as specifications, procedure manuals, and technical documents related to Medical Device alerts and recalls
• Medical device alert and recall experience
• Demonstrated working knowledge of FDA, federal, state, and accreditation requirements relevant to Patient Safety and adverse event reporting
• Ability to maintain and handle confidential or sensitive information and materials
• Validated leadership skills with managing and communicating critical information at multiple levels both internally and externally
• Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures
• Demonstrated ability to multi-task and manage time sensitive projects
• Proficient in English language with excellent communication skills, both oral and written
• Demonstrated ability to perform data analysis activities, including trending analysis, root cause analysis and implementation of CAPA plans
• Demonstrated ability to influence, while maintaining independent and objective views
• Demonstrated ability to maintain high ethical standards, including a commitment to organizational values and behaviors
• Proven analytical skills
• Extensive experience with Microsoft office applications

Education and Qualifications

• Bachelor's Degree in Business, Healthcare Quality, Regulatory or a relevant technical field

• At least 5 years of experience in clinical engineering, healthcare quality, regulatory compliance, risk, or Medical Device industry

#LI-Hybrid