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Quality & Regulatory Affairs Analyst

InsideHigherEd
Arlington, TX Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/17/2025

Posting Number : S05969P

Position Title :

Quality & Regulatory Affairs Analyst

Department : TMAC

Location : Arlington

Job Family : Research

Position Status : Full-time

Work Hours : Standard

Work Schedule :

Monday-Friday; 8 : 00am-5 : 00pm.

  • Overtime as necessary to fulfill customer requirements.
  • Projects and assessments may require extended hours onsite to ensure thorough evaluation.
  • Regular travel to various client sites which may be located regionally or across the state of Texas.
  • Some interstate travel may be required as customer demand and grant obligations

determine.

Open to :

External and Internal

Salary :

Salary is commensurate based on qualifications and relevant experience up tp $120,000.

Duration :

Funding expected to continue

Pay Basis : Monthly

Benefits Eligible : Benefits at UTA :

We are proud to offer a comprehensive benefits package to all our employees at the University.

https : / / www.uta.edu / hr / employee-benefits

To help you understand the full value of these benefits, we have created a tool that calculates the total worth of your compensation package. This tool takes into account all of the benefits that you are eligible for, including health insurance, retirement plans, and paid time off. To access this tool and learn more about the total value of your benefits, please click on the following link :

https : / / resources.uta.edu / hr / services / records / compensation-tools.php

University Information :

The University of Texas at Arlington is located in the heart of the Dallas-Fort Worth-Arlington metroplex, a vibrant and diverse metropolitan area that is home to over 7 million people, one of the fastest-growing tech economies in the United States, and a wide array of arts, entertainment, and cultural activities. UTA is a comprehensive teaching, research, and public service institution dedicated to the advancement of knowledge through scholarship and creative work. The University is committed to providing access and ensuring student success, and to a culture of innovation, entrepreneurship, and commercialization of discoveries by our community of scholars. With an enrollment of more than 40,000 students, UTA is the second largest in the University of Texas System. As a result of its combination of rigorous academics and innovative research, UTA is designated as a Carnegie R-1 “Very High Research Activity” institution. UTA ranks No. 4 nationally in Military Times’ annual “Best for Vets : Colleges” list and is among the top 30 performers nationwide for promoting social mobility of its graduates (U.S. News & World Report, 2023). UTA is designated by the U.S. Department of Education as both a Hispanic-Serving Institution (HSI) and an Asian American and Native American Pacific Islander-Serving Institution (AANAPISI), and it has one of the top 5 most ethnically diverse undergraduate student bodies in the United States (U.S. News & World Report, 2023). Its approximately 270,000 alumni, including some who occupy leadership positions at many of the 24 Fortune 500 companies headquartered in North Texas, contribute to UTA’s $22.2 billion annual economic impact on Texas.

Furthermore, UTA is poised to experience widespread growth in the near future. The university recently launched the first phase of its RISE 100 initiative aimed at recruiting 100 new tenure-system faculty to amplify research standing and position UTA as a leader in key scholarly areas; more details are available at https : / / www.uta.edu / administration / president / strategic-plan / rise100 . The successful candidate for this position will have the opportunity to join UTA during an exciting period of growth and contribute as the university broadens its impact.

Job Summary :

The Quality & Regulatory Affairs Analyst delivers hands-on quality management and regulatory affairs solutions to a wide range of businesses including manufacturing, distribution, logistics, construction, health care, and government. Contribute to TMAC’s wide array of services that accelerate profitable growth and competitiveness of

Texas manufacturing by developing and improving profits, products,

processes, technologies, and people.

Essential Duties and Responsibilities :

  • Generate leads, conduct assessments, prepare proposals, and
  • support events.

  • Assist with the implementation of various ISO standards (ISO 9001, AS 9100, ISO 13485, ISO 14971, FDA Requirements (Good Manufacturing Practices – GMP and Good Laboratory Practices – GLP), and Production Part Approval Process (PPAP) for TMAC customers in various industries.
  • Customize the implementation process to meet the specific needs of each organization.
  • Provide comprehensive training and coaching to customers on ISO standards and best practices.
  • Conduct internal audits to assess compliance with ISO standards.
  • Identify areas for improvement and provide actionable recommendations.
  • Assist companies in preparing for ISO certification audits, ensuring all necessary criteria are met.
  • Integrate knowledge, culture, and governance in deployments.
  • Quality Improvement process solutions techniques, such as Strategic Planning, CAPA, and Risk assessment, training.
  • Conduct audits, generate audit reports, and assist customers with follow up on the audit results.
  • Assist with project implementations.
  • Earn advanced and / or multiple certifications as required.
  • Manage accounts having multiple projects across multiple product lines.
  • Demonstrate effective project execution, project management, project results, and customer follow-up.
  • Identify the financial impact of projects upon completion.
  • Performs other duties assigned.
  • Minimum Qualifications :

  • Bachelor’s degree in science, technology, engineering, math (STEM), or related field.
  • Minimum of two (2) years of experience in manufacturing, quality consulting, or a related field.
  • Proficiency in MS Office Suite.
  • Preferred Qualifications :

  • Master’s degree in science, technology, engineering, math (STEM), or related field.
  • Two (2) years of experience in manufacturing, quality consulting, or a related field. Experience using Salesforce.
  • Preferred certifications :
  • Lead auditor (AS9100, ISO 13485, ISO 9001), European Union

    Medical Device Regulation, Lean Six Sigma Black Belt

    Knowledge, Skills and Abilities :

  • Knowledge of ISO standards, particularly ISO 9001, ISO 13485, ISO 14971, and AS9100
  • Understanding of quality management systems and best practices
  • Project management skills, with the ability to oversee multiple initiatives simultaneously.
  • Analytical skills and proficiency in designing and implementing QMS.
  • Excellent written and verbal communication skills from front-line staff to C-Level suite
  • Creative problem-solving abilities for developing innovative solutions
  • Ability to build and maintain strong customer relationships, exhibit leadership to guide customer teams, and demonstrate high attention to detail.
  • Adaptability to diverse client needs and dynamic project requirements
  • Strategic thinking to align initiatives with organizational goals, ensures their ability to drive sustainable growth and operational excellence in manufacturing companies.
  • Other Requirements :

  • Understanding of local, state, and federal regulations related to manufacturing in certain high-target industries (Medical, Aerospace, Pharmaceuticals, and others).
  • Working Conditions :

  • May be exposed to industrial settings or manufacturing plants that could be hazardous.
  • Conditions could consist of extreme temperatures, high noise levels, and poor air quality.
  • Industries could be working in chemical processing, oil and gas, and manufacturing processes that could be at risk for fire.
  • Slips, trips, and falls are common hazards in manufacturing environments.
  • Manufacturing facilities could operate 24 / 7 requiring visits to different shifts including odd hours of the day / week.
  • Projects and assessments may require extended hours onsite to ensure thorough evaluation. Overtime may be needed to fulfill customer requirements.
  • CBC Requirement :

    It is the policy of The University of Texas at Arlington to conduct a criminal background check on any applicant who is under final consideration for employment with the University.

    EEO Statement :

    It is the policy of The University of Texas at Arlington (UTA or The University) to provide an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of race, color, national origin, religion, age, sex, sexual orientation, pregnancy, disability, genetic information, and / or veteran status. The University also prohibits discrimination on the basis of gender identity, and gender expression. Retaliation against persons who oppose a discriminatory practice, file a charge of discrimination, or testify for, assist in, or participate in an investigative proceeding relating to discrimination is prohibited. Constitutionally-protected expression will not be considered discrimination or harassment under this policy. It is the responsibility of all departments, employees, and students to ensure the University’s compliance with this policy.

    ADA Accommodations :

    The University of Texas at Arlington is committed to providing reasonable accommodation to individuals with disabilities. If you require reasonable accommodation in completing this application, interviewing or otherwise participating in the employee selection process, please direct your inquiries to 817-272-5554 or email ADADocs@uta.edu .

    Number of Vacancies :

    Minimum Number of References Required :

    Maximum Number of References Accepted :

    Special Instructions to Applicants :

    Applicants must include in their online resume the following information : 1) Employment history : name of company, period employed (from month / year to month / year), job title, summary of job duties and 2) Education : school name, degree type, and major.

    Salary : $22 - $120,000

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