Quality & Regulatory Compliance Analyst (Hybrid)

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 standards
• Compile data and perform analysis for equipment make/models/description and modalities, as well as equipment risk to ensure standardized MMD creation, maintenance and improvement
• Support Quality and Regulatory Specialists with reporting criteria and analysis of effectiveness verification post audit and CAPA completion
• Identification, monitoring and assistance with risk/opportunity assessment across the organization
• Provide oversight, monitoring and analysis with regulatory compliance requirements
• Assist with MMD matching of new and existing customer inventory in accordance with TRIMEDX MMD standardization processes and best practices
• Conduct analysis and comparison of alerts and recalls in determining impact to TRIMEDX organization and timely closure of loop
• Monitor, measure and produce QRC reporting necessary for Quality Management Review on a monthly/quarterly basis
• Support Quality and Regulatory Specialists with reporting criteria during site inspections and surveys

QRC 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 gaps
• Based on data analysis results and organizational feedback; partner with cross functional areas when the development of new processes, products, services, or relationships is required
• Develop best practices and business rules to ensure uniformity in work, deliverables and outcomes
• Assist with creation, analysis and maintaining standardized reporting of Pilgrim CAPA progress and effectiveness verification
• Creation, maintenance and improvement of data audit and remote internal audit tool for QRC team and external field facing documentation
• Participate 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 frequencies
• Monitor, measure and communicate compliancy gaps and risks in a timely manner to ensure mitigation of risks to patient safety and compliance
• Demonstrate competency as a QRC subject matter expert for RSQ and QMS software program analysis
• Assist 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 needs
• Create and deliver QRC presentation data support and communications to peers, functional area leaders, and executives
• Collaborate with QRC team and Field Operations to ensure timely deliverables requested on behalf of surveyor during regulatory and accreditation survey process
• Participate in PM Variance and AEM Committees to share QRC analysis with group to drive outcomes based upon compliancy

All 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 solving
• Experience with complex reporting and analysis to ensure QRC data integrity and compliancy
• Strong 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 regulations
• Knowledge of healthcare industry, regulatory compliance, clinical engineering, medical technology, and/or healthcare support services preferred
• Knowledge of ISO 9001, 13485 and/or 27001 preferred
• Strong analytical and interpretation skills to understand complex regulations and data analysis related to compliancy
• Strong written and verbal communication skills supporting interactions with personnel at all levels within the organization
• Creative thinker with ability to meet stringent and changing deadlines with accuracy
• Change management and customer focused

Education 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.