Quality & Regulatory Specialist II

TRIMEDX•Indianapolis, IN

8d•Hybrid

About The Position

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 here. 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. 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

Requirements

ISO 13485, 9001 and/or 27001 internal audit experience preferred
Minimum of 2 years of experience in clinical engineering, healthcare quality, compliance, risk, or medical device industry
Experience with interpreting Clinical Engineering, Healthcare regulations, and/or ISO standards
Basic working knowledge of quality management system and risk management
Ability to participate in multiple projects in a team environment
Proven analytical and problem-solving skills to diagnose and resolve issues
Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
Organization and time management skills
Process and continuous improvement oriented
Self-starter and ability to multitask
Strong written, verbal, and presentational communication skills
Basic to intermediate Excel skills; with ability for data reporting and analysis
Conflict management skills
Ability to travel as required up to 30% of the time.
Bachelor’s degree or equivalent experience in a related healthcare field, applied science, QMS, or clinical engineering required (Associate degree consideration given with direct experience)

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 Operations site performance of repairs, PM, and management of alerts and recalls, to maintain compliance and perform internal audit activities
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and external inspectors through all stages of the audits in accordance with ISO 13485 and 27001 standards and/or medical device regulations
Prepares reports and/or necessary documentation (I.E. Corrective and Preventative Actions) and provides to applicable internal and/or external stakeholders
Participation in the CAPA Review Board process as requested
Conducts effectiveness verification and sampling of completed CAPAs to ensure proper execution
Conducts ongoing monitoring and measurement of quality and regulatory dashboards and risk mitigation activities
TRIMEDX Operations Support (15%)
Provide telephone/remote support to Field Operations team
Support and resolve Quality and Regulatory Compliance ServiceNow Tickets
Create and facilitate Quality and Regulatory Compliance education to hospital Safety and Risk personnel, as well as TRIMEDX Field Operations
Manage PM standardization and alignment for like and kind MMD, based upon Quality and Regulatory environment requirements
Maintain and support the AEM (Alternative Equipment Maintenance) Program Review with TRIMEDX Operations (requires qualified Clinical Engineer participation). This is an approval committee for submitted changes to medical equipment PM frequencies based upon required documentation and trending
Lead Quality and Regulatory Compliance efforts for reverse and new implementations
All other duties as assigned