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 .
Summary
The Quality and Regulatory Compliance Analyst is an integral role in producing standard compliance data for accreditation and regulatory surveys, internal QRC and Supplier Quality audits and data audits, CAPA effectiveness, as well as normalized and standardized MMD categorization. This position will work directly with the Quality and Regulatory Compliance team, as well as field operations to drive reporting, analysis and data integrity regarding compliancy to Accreditation Standards, as well as Federal, State and Local Regulations. The Quality and Regulatory Compliance Analyst leverages large and varied datasets to support compliance initiatives and programs across the organization.
Responsibilities
Compliance Analytics and Reporting (50%)
Conduct targeted analysis of repair and preventive maintenance data related to QRC internal audits and data audits criteria to ensure compliancy to federal state and local regulations and accreditation standardsCompile data and perform analysis for equipment make / models / description and modalities, as well as equipment risk to ensure standardized MMD creation, maintenance and improvementSupport Quality and Regulatory Specialists with reporting criteria and analysis of effectiveness verification post audit and CAPA completionIdentification, monitoring and assistance with risk / opportunity assessment across the organizationProvide oversight, monitoring and analysis with regulatory compliance requirementsAssist with MMD matching of new and existing customer inventory in accordance with TRIMEDX MMD standardization processes and best practicesConduct analysis and comparison of alerts and recalls in determining impact to TRIMEDX organization and timely closure of loopMonitor, measure and produce QRC reporting necessary for Quality Management Review on a monthly / quarterly basisSupport Quality and Regulatory Specialists with reporting criteria during site inspections and surveysQRC Tools, Processes and Program (30%)
Lead QMS internal audit activities (per ISO 13485, 27001 and / or applicable regulatory standards)Create, manage and monitor PM Transition Plan and Tools for new site implementations and existing sites with PM compliancy gapsBased on data analysis results and organizational feedback; partner with cross functional areas when the development of new processes, products, services, or relationships is requiredDevelop best practices and business rules to ensure uniformity in work, deliverables and outcomesAssist with creation, analysis and maintaining standardized reporting of Pilgrim CAPA progress and effectiveness verificationCreation, maintenance and improvement of data audit and remote internal audit tool for QRC team and external field facing documentationParticipate in AEM (Alternative Equipment Maintenance) and PM Variance Committee by producing pertinent data pull and analysis related to PM Frequency Change and AEM Program requests and speak to outcome of analysis to committee members to drive decision making processes related to equipment risk and PM frequenciesMonitor, measure and communicate compliancy gaps and risks in a timely manner to ensure mitigation of risks to patient safety and complianceDemonstrate competency as a QRC subject matter expert for RSQ and QMS software program analysisAssist with prompt response and actions related to QRC ServiceNow requests (PM Frequency Changes, PM Not Needed Requests, AEM Program Review, Bulk QRC requests)Communication and Interactions (20%)
Collaborate with cross functional business leaders to capture and document QRC reporting and analytics needsCreate and deliver QRC presentation data support and communications to peers, functional area leaders, and executivesCollaborate with QRC team and Field Operations to ensure timely deliverables requested on behalf of surveyor during regulatory and accreditation survey processParticipate in PM Variance and AEM Committees to share QRC analysis with group to drive outcomes based upon compliancyAll other duties as assigned.
Skills and Experience
Minimum of 3 years of experience in clinical engineering, quality, compliance, with demonstrated competency in data analysis, reporting, and application of problem solvingExperience with complex reporting and analysis to ensure QRC data integrity and compliancyStrong demonstrated proficiency with Microsoft Office applications; advanced skills with Advanced Excel and Access required (Sequel, Qlik, Tableau experience a plus)Basic knowledge and application of ISO 13485, 9001 and / or 27001 standards and applicable regulationsKnowledge of healthcare industry, regulatory compliance, clinical engineering, medical technology, and / or healthcare support services preferredKnowledge of ISO 9001, 13485 and / or 27001 preferredStrong analytical and interpretation skills to understand complex regulations and data analysis related to compliancyStrong written and verbal communication skills supporting interactions with personnel at all levels within the organizationCreative thinker with ability to meet stringent and changing deadlines with accuracyChange management and customer focusedEducation and Qualifications
Associates degree in Quality and / or Regulatory Compliance, Clinical Engineering, Applied Science or Business equivalent or equivalent experience required.Bachelor's degree preferred.At TRIMEDX, we support and protect a culture where diversity, equity and inclusion are the foundation. We know it is our uniqueness and experiences that make a difference, drive innovation and create shared success. We create an inclusive workplace by actively seeking diversity, creating inclusion and driving equity and engagement.
We embrace people's differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences.
Visit our website to view our full Diversity, Equity and Inclusion statement, along with our social channels to see what our team is up to : Facebook , LinkedIn , Twitter .
TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace.
Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working / on-call hours.
