Quality & Regulatory Specialist II

Location: Indianapolis

** If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.
*** Everyone is focused on serving the customer and we do that by collaborating and supporting each other
* Associates look forward to coming to work each day
* Every associate matters and makes a difference

It is truly a culture like no other — We hope you will join our team! Find out more about our company and culture .The Quality & Regulatory Compliance Specialist II is responsible for conducting research, interpretation, education, and adherence to medical device QMS and accreditation/regulatory standards (state, federal and local).  The position is responsible for execution of a Quality Management System and Regulatory Compliance Program inclusive of executing internal audits, CAPA issuance and effectiveness verification, medical device alert and recall management, patient/equipment incident management, AEM program management, and adherence to QMS policies, procedures and work instructions.
The ability of the business to meet its objectives and to remain compliant depends on the output and reliability of the day-to-day operations of the Quality and Regulatory Compliance team. As such, the Quality and Regulatory Specialist II must be able to continually adapt to the evolving Quality and Regulatory landscape and demands.
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* Location:

** Indianapolis, Indiana; candidates must currently reside in the central Indiana region; within a 70 mile range of Indianapolis. Position is hybrid (a mix of in-office, remote, as well as 30% required business travel).
* Relocation is not available for this position
* Immigration sponsorship not available for this position
** Responsibilities
* * Regulation Research, Interpretation and Education (30%)
* Provides oversight for the development and maintenance of Field Operations QMS processes and procedures that ensure that the performance and quality of services conform to established internal and external standards, regulations, and guidelines
* 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 customer and internal stakeholders)
Manage and Maintain Quality and Regulatory Compliance Program (25%)
* Provides expertise and guidance during external Field Operations surveys and/or audits
* Promotes a culture of Quality across the organization that ensures commitment and understanding of ISO and Regulatory requirements
* Accountable as QRC subject matter expert ensuring support of QMS compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape
* Engages legal team when applicable in support of government investigations or litigations
* Ensures the Field Operations programs and documentation is maintained and modified regularly
* Utilizes metrics and reporting to effectively monitor processes, report on performance, drive improvement throughout the organization
* Maintains, assesses gaps, and updates TRIMEDX documentation according to applicable regulations and standards in a timely manner in effort to remain current regarding Quality and Regulatory Compliance
* Influences and advises TRIMEDX Operational processes in effort to mitigate risk
* Employs and shares best practices and tools to accelerate continual quality improvement

Quality and Regulatory Compliance Audits (30%)
* Monitors and measures Field…