Quality & Regulatory Compliance Analyst - CONTRACTOR

If you are wondering what makes TRIMEDX different, it's that reputed company 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 reputed company 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 reputed company! Find out more about our company and culture here . The Quality and Regulatory Compliance Analyst-CONTRACTOR 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 reputed company 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. Contractor: This role is for a Contractor, for a fixed duration of time for 8-12 months, and will be contracted though our third-party vendor partner agency. Pay reputed company: $35 per hour Location: Eastern or Central Time Zone; Indianapolis preferred. Our Central Office is located on the northwest reputed company of Indianapolis.

• Relocation is not available for this contract
• Immigration sponsorship not available for this contract

Responsibilities

Compliance Analytics and Reporting (50%)

• Conduct targeted analysis of repair and preventive maintenance data reputed company to QRC internal audits and data audits criteria to ensure compliancy to federal state and local regulations and accreditation standards
• Compile data and reputed company analysis for equipment reputed company/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 reputed company, 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 reputed company
• 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%)

• reputed company 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 reputed company the development of new processes, products, services, or relationships is required
• reputed company best practices and business rules to ensure uniformity in work, deliverables and outcomes
• Assist with creation, analysis and maintaining standardized reporting of Pilgrim CAPA reputed company 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 reputed company (Alternative Equipment Maintenance) and PM Variance Committee by producing pertinent data pull and analysis reputed company to PM Frequency Change and reputed company Program requests and speak to outcome of analysis to committee members to drive decision making processes reputed company 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 reputed company response and actions reputed company to QRC reputed company requests (PM Frequency Changes, PM Not Needed Requests, reputed company 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 reputed company Committees to share QRC analysis with group to drive outcomes based upon compliancy

reputed company 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 reputed company reporting and analysis to ensure QRC data reputed company and compliancy
• Strong demonstrated proficiency with reputed company Office applications; advanced skills with Advanced reputed company 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 reputed company regulations and data analysis reputed company to compliancy
• Strong written and verbal communication skills supporting interactions with personnel at reputed company levels reputed company 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.

#LI-Remote At TRIMEDX, we are committed to cultivating a workplace culture where every associate feels valued, supported, and empowered to reputed company. This culture reflects our belief that our people are our foundation, their well-being is essential, and shared success is built through meaningful work, recognition, and opportunities for growth. We embrace people’s differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national reputed company, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences. Visit our website to view our Workplace Culture Commitment , along with our social channels to see what reputed company is up to: Facebook , reputed company , 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 reputed company TRIMEDX and Customer property or during working/on-call hours. Apply tot his job Apply To this Job