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Ability to meet deadlines, monitor and assess performance within deadlines and utilize resources appropriately to ensure accurate and timely deliverables. Independently gather information from technical and non-technical Subject Matter Experts to organize, develop, and write technical service content.

Job Title: Diagnostic Engineer /Customer Service Technical Content author 
Location: 
Woodridge, Illinois 
Onsite/ Remote: Day 1 Onsite at customer location 
Job Description: Diagnostic Engineer /Customer Service Technical Content author 
Experienced in vehicle mechanics for more than 4 years at service advisor or at dealership 
Experience in automotive/truck support aftermarket services 
To identify gaps between recalls and service content or repair information available for that. And provide solution accordingly. 
Prior hands on automotive/diesel experience working with step based published diagnostics 
Microsoft familiarization (Outlook, TEAMS, Excel, PowerPoint, etc.) 
Comprehends dealer facing step-based diagnostics 
Willingness to get to the root cause of the problem 
Willingness to identify problems while also proposing solutions 
Communicate effectively through phone, email, or chat 
Wanting to make a difference and challenge the process 
Being well organized and tracking identified items inside a repository 
Ability to meet deadlines, monitor and assess performance within deadlines and utilize resources appropriately to ensure accurate and timely deliverables 
Ability to multitask, prioritize tasks, and interface with many personalities 
Strong communication skills: ability to take complex engineering concepts and explain them at an appropriate audience level 
Experience with vehicle recalls and provide corrective action plans 
Independently gather information from technical and non-technical Subject Matter Experts to organize, develop, and write technical service content 
Strong Technical Diagnostic Step Based Understanding 
Strong Root Causal Understanding (LEAN, 5 Why's, 6 Sigma) 
Strong Attention to Detail (Comparing, Investigating, Identifying) 
Customer Focused (What's The Right Thing To Do) 
Good understanding of Agile environment 
Excellent verbal and written communication skills 
To work with cross-functional Teams 
Ability to Multi-task on various projects 
Strong MS Office tools experience including, Word, Excel, SharePoint and OneNote 
Extremely Organized on tasks (What Are You Working On, What Are You Waiting On, What Do You Need Help With, What Is Next In Line) 
Understanding of structured authoring (DITA) and basic knowledge of Arbortext 
Knowledge of automotive system theory, in any or all the following areas: 
Electronic and electrical fundamentals 
Mechanical procedures 
Modern automotive systems 
“*** is an Equal Employment Opportunity employer. We promote and support a diverse workforce at all levels of the company. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin, or disability. All applicants will be evaluated solely based on their ability, competence, and performance of the essential functions of their positions with or without reasonable accommodations. Reasonable accommodations also are available in the hiring process for applicants with disabilities. 
Candidates can request a reasonable accommodation by contacting the company ADA Coordinator at 
*** 
.”

Yantran LLC

JD Diagnostic Engineer /Customer Service Technical Content author

Agile Programming Methodologies

Arbortext

Automotive Industry

Communication Skills

Corrective Action

Cross-Functional

Customer Relations

Customer Support/Service

Data Collection

Detail Oriented

Establish Priorities

Identify Issues

Lean Six Sigma

Microsoft Excel

Microsoft Office

Microsoft SharePoint

Microsoft Word

Multitasking

Organizational Skills

Performance Analysis

Presentation/Verbal Skills

Six Sigma

Technical Writing

Time Management

Writing Skills

jobdiva

OTHER

This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. Position Summary: This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines.

YEAR

Overview:
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:
This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines. This role supports the overall quality program and serves as a liaison between the Regulatory Affairs/Quality team and other service lines of Versiti. He/she/they partners with service lines to provide regulatory affairs input on projects and everyday tasks.

Total Rewards Package:
Compensation The target salary for this position is $83,745 annually.  The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications. Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities:
<ul><li>Core Quality Responsibilities * Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. * Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions. * May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for regulatory affairs, as required. * Reviews regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management. * Participates and may lead in the development, compilation, and submission of regulatory submissions as required. * May review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions. * Completes the review of events to assess impact. * Acts a resource for regulatory and quality matters.</li><li>Specific Senior Regulatory Affairs (RA) Specialist Responsibilities * Authors and prepares documentation for regulatory submissions * Provides internal and external regulatory guidance and development of regulatory strategies * Maintains awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation * Maintains facility registrations for Versiti * Review documentation and make determination of submission to regulatory agencies, as applicable * Coordinates and consults with other functions on the content and assembly of regulatory documentation and ensures consistency, completeness, and adherence to standards for all the regulatory submission * Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed * Leads and tracks regulatory projects * Support junior-level RA Specialists in project execution and/or day-to-day RA tasks</li><li>Performs other duties as assigned</li><li>Complies with all policies and standards</li></ul>

Qualifications:
Education<ul><li>Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required</li><li>Master's Degree preferred</li></ul>Experience<ul><li>4-6 years of experience in related field required</li><li>4-6 years of experience with a master's degree required</li><li>Experience in Regulatory Submissions and facility registrations required</li><li>Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred</li></ul>Knowledge, Skills and Abilities<ul><li>Advanced knowledge of the principles and practices within Regulatory Affairs (requiring academic preparation and experience)</li><li>An experienced professional qualified in Regulatory Affairs, and possess experience in other complex technical area(s)</li><li>Requires advanced knowledge and application of external standards and regulations that impact related disciplines.</li><li>Determines and implements a course of action based on regulations, standards, and guidelines, and may modify processes and methods as required</li><li>Requires knowledge of company policies, practices, and procedures or ability to quickly gain applicable knowledge</li><li>Require knowledge and application of external standards and regulations.</li><li>Ability to use professional concepts and company's policies and procedures to solve a variety of problems</li><li>Strong written communication and business acumen skills</li><li>Proficiency in Microsoft Office</li><li>Possess strong attention to detail</li><li>Ability to read, interpret and disseminate applicable regulations and standards</li><li>Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred</li></ul>Licenses and Certifications<ul><li>Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, RAPS RAC) preferred</li></ul>Tools and Technology<ul><li>Personal Computer (desktop, laptop, tablet) required</li><li>General office equipment (computer, printer, fax, copy machine) required</li><li>Microsoft Suite (Word, Excel, PowerPoint) required</li><li>Gap Assessment Tools for Standards/Regulations required</li></ul> <ul class="job-list-job-card__tags"><li class="job-list-job-card__tag t-14 t-black--light">#LI-Hybrid</li><li class="job-list-job-card__tag t-14 t-black--light">#LI-AB1</li></ul>

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JD Diagnostic Engineer /Customer Service Technical Content author Yantran LLC

Senior Regulatory Affairs Professional Versiti, Inc.

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