Manager, QRC Risk Management

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• 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 Manager, QRC Risk Management, is responsible for leading a team of risk management analysts, as well as developing and administering a medical equipment risk mitigation and risk management program. This role will provide strategic direction and execution of a risk management program ensuring regulatory compliance to Alternative Equipment Maintenance (AEM), Manufacturer/Model/Description (MMD) Categorization, Preventive Maintenance (PM) Variances, and End of Life/End of Service (EOL/EOS) throughout the lifecycle of TRIMEDX medical equipment inventory.

Responsibilities

Quality and Regulatory Risk Management Program (60%)

* Develop and implement normalized and standardized equipment (Make, Model and Description - MMD) categorization and set-up processes to meet key departmental leader's operational requirements.

* Create, Implement, and maintain a performance measurement plan to ensure timely data collection, aggregation, and analysis, of AEM, MMD, EOL/EOS, and PM Variance Programs.

* Execute the vision, strategy, and implementation of all pivotal outcomes related to AEM, MMD, EOL/EOS and PM Variance programs.

* Define, implement, manage and execute program objectives, including the tracking of metrics and key performance indicators to evaluate program effectiveness.

* Collaborate with diverse cross-functional teams to evaluate existing program controls for AEM, MMD, EOL/EOS, Service Manuals and PM Variances) and lead program change management.

* Manage and maintain Operations Variance, AEM, MMD Committee requirements, inputs and outputs and communicate with senior leadership on progress to goals and alignment with deliverables.

* Manage and oversee the execution of quality and regulatory data audits specific to AEM, MMD, PM variance and Service Manual activities to ensure compliancy to ISO 13485 and/or 27001 standards.

* Evaluate equipment, assets, tools, and maintenance records to ensure that the Medical Equipment Inventory categorization and CMMS system are standardized and accurate.

* Monitor, manage, and execute reporting trends of the AEM, MMD, EOL/EOS, PM Variance processes in efforts to mitigate TRIMEDX risk.

* Monitor and manage timely execution of equipment risk activities and processes to ensure patient safety in all equipment related processes.

* Oversee the analysis of TRIMEDX medical equipment maintenance program data and make recommendations to optimize quality, efficiency, and maintenance activity performance.

* Provide periodic benchmarking reports and trending consistent with accreditation and regulatory requirements.

* Ensure data completeness and integrity to maximize the effectiveness of medical equipment maintenance program.

* Conduct root cause analysis, and proactive medical equipment risk assessments, as well as policy and procedure evaluations and revisions.

* Create, implement, and lead process mapping, optimization, and gap analysis of the TRIMEDX medical equipment categorization and preventive maintenance risks and variances.

* Facilitating QRC risk management program success through the utilization of appropriate metrics and methodologies.

* Ability to evaluate practical and technical information from manufacturers, contract specifications, manuals, and historical data to perform analysis required to make effective recommendations to the organization concerning preventive maintenance frequency strategies for medical equipment.

Leadership (40%)

* Provide direction and leadership to the QRC Risk Management Analysts to achieve goals and objectives, as well as drive engagement and performance.

* Ability to lead, monitor, measure, and enhance cross functional AEM, MMD, EOL/EOS, Operations and PM Variance program initiatives throughout the organization.

* Demonstrate leadership skills and qualities in actions to lead a high performing team.

* Manage annual operating budget and provide direction to team regarding departmental expenses.

* Collaborates with cross-functional teams and leaders throughout the organization to implement results-oriented solutions that utilize technology and analysis of QMS trends related to equipment risk.

* Exemplify strategic thinking and collaborative decision making.

* Provide leadership and role modelling through organizational involvement and a commitment to living out the company's core values.

* Demonstrate and instill quality culture throughout the team.

* Organize and prioritize projects and resources to manage efficiency for the team, as well as internal and external stakeholders.

* Leadership: Provide clear direction to ensure collective achievement of goals and objectives. Create an environment of respect, collaboration, and open communication.

* Associate Development: Identify and support development needs of direct reports and team members including connecting them to resources both internally and externally to ensure a culture of continuous improvement.

* Associate Engagement: Create high levels of employee engagement by understanding organizational and personal drivers that impact drivers and developing action plans that deliver increased engagement.

* Performance management: Set clear goals and expectations for teams, monitor, and enable performance and intervene with appropriate action when performance gaps occur and provide timely, honest feedback. Ensure that associates complete assigned actions by required deadlines.

* All other duties as assigned.

Skills and Experience

* Minimum 5 years of experience in clinical engineering or hospital risk management, and/or quality & regulatory compliance is required. A minimum of three years of experience managing a team is required.

* Knowledge and/or experience in internal data audits to ISO 9001, 13485 and/or applicable regulatory standards is required.

* Change management agent.

* Experience in data analysis and trending required.

* Advanced knowledge and use of Microsoft Office applications required(Word, Excell, PowerPoint, Outlook)preferred.

* Strategic thinking and in-depth analytical problem-solving.

* Results orientation driven by KPIs and metrics; knowledge of statics and analytical tools.

* Ability to champion the vision of change as an opportunity and overcome resistance.

* Lead both influentially as well as directly along with coaching and mentoring .

* Strong group facilitation skills, including excellent active listening skills; have the self-confidence to involve multiple levels of leadership and act in a boundary-less fashion.

* Conflict resolution skills including persuasive management techniques required.

* Superior training, consulting, and influencing skills.

* Effective written, verbal, and presentational communication skills.

Education and Qualifications

* Bachelor's degree in clinical engineering, healthcare management, data quality and/or regulatory compliance or related field required, or equivalent experience.

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.