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TRIMEDX · 11 hours ago

Quality & Regulatory Specialist II

Indianapolis, IN

Full-time

Hybrid

Entry, Mid Level

2+ years exp

TRIMEDX is dedicated to serving clients, patients, and communities with a commitment to quality and performance. The Quality & Regulatory Specialist II is responsible for ensuring compliance with medical device regulations and standards, managing the Quality Management System, and conducting audits to maintain regulatory adherence.

Asset ManagementHealth CareHospital

No H1B

Responsibilities

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

Provides 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)

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

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

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

Qualification

ISO 13485Regulatory ComplianceQuality Management SystemClinical EngineeringAnalytical SkillsMicrosoft OfficeContinuous ImprovementProblem-Solving SkillsCommunication SkillsTime Management

Required

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)

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