Southwest Research Institute (SwRI)

QUALITY ENGINEER - QUALITY SCIENTIST - SR. QUALITY ENGINEER - Quality Management System Auditor

Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical, Electrical, Chemical, Industrial Engineering, Computer Science, Aerospace Engineering, or Materials Engineering, or a related field.
  • 2-10 years of experience in process-based auditing, quality engineering, quality assurance, or similar roles.
  • Familiarity with certified quality management systems like ISO 9001, AS9100, or ISO/IEC 17025.
  • Relevant experience in a scientific, engineering, laboratory, manufacturing, or research environment.
  • Strong analytical skills to interpret quality data and trends.

Responsibilities

  • Conduct internal quality system audits and assessments for compliance and improvements.
  • Assist in planning and coordinating audits with stakeholders and internal customers.
  • Perform thorough documentation reviews, inspections, and evaluations of organizational effectiveness.
  • Analyze audit results and provide well-documented findings and recommendations.
  • Collaborate with teams to address quality issues and share best practices.
  • Engage with cross-functional teams to foster a consistent quality culture throughout the organization.
  • Support continual enhancement of the internal audit program, including procedures and training.

Benefits

  • Opportunities for professional development and auditor certification.
  • Collaborative work environment within diverse scientific and engineering disciplines.
  • Chance to influence quality standards and operational efficiency.
  • Engagement with cross-functional teams to address complex quality challenges.
Full Job Description
  • Conduct internal quality system audits and assessments ensuring compliance with quality management systems, standards, and regulations to ensure we meet our customer's needs.
  • Support the Department's continual improvement efforts as an Internal Quality System Auditor by identifying opportunities to enhance documentation, procedures, and operational efficiency across a diverse range of scientific and engineering disciplines.
  • Minimize risk, maintain regulatory compliance, and strengthen the quality culture through thorough audits, assessments, and evaluations.
  • Provide valuable insights and recommendations as an Internal Quality System Auditor, contributing to high-quality research outcomes, effective processes, and client satisfaction.
  • Ensure precision, reliability, and adherence to quality standards while fostering trust among clients and stakeholders.
  • Conduct on-site audits and surveillances to assess conformity to quality management systems, processes, and product requirements.

  • Review and assist the Department in planning audits. This involves coordinating with relevant stakeholders, scheduling audits with internal customers, and preparing the necessary documentation and checklists.
  • Perform documentation review, inspections, interviews, and observations to evaluate adherence to established standards and organizational effectiveness.
  • Analyze results and document findings, observations, recommendations, and supporting objective evidence.
  • Ensure audit reports are accurate, well-documented, and delivered to relevant stakeholders in a timely manner.
  • Collaborate with audit team members and internal stakeholders regarding audit results, corrective actions, and improvement plans.
  • Engage with cross-functional teams, such as engineering, quality assurance, and production, to address quality-related issues and identify opportunities for improvement.
  • Share lessons learned and effective practices across technical divisions.
  • Support improvements to the Institute's internal audit program, including procedures, work instructions, checklists, templates, and training.
  • Support development of a strong and consistent quality culture throughout the Institute.

  • Requires a Bachelors degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Industrial Engineering, Computer Science, Aerospace Engineering, Materials Engineering
  • Chemistry or related degree field with relevant experience.
  • Auditor Certification desired
  • 2-10 years: Process-based auditing, quality engineering, quality assurance, or related experience.
  • 2-10 years: Working within a certified or formally implemented quality management system, such as ISO 9001, AS9100, ISO/IEC 17025, or a comparable industry or national standard. Knowledge of quality, aerospace, environmental, laboratory, nuclear, or other regulated-industry standards.
  • 2-10 years: Experience working in a scientific, engineering, laboratory, manufacturing, or research environment. Experience analyzing quality data, trends, or performance metrics. Comfortable working with people across different technical disciplines and levels of the organization.
  • Must have excellent communication and interpersonal skills.
  • Looks beyond individual findings to identify trends and opportunities for systemic improvement.
  • Values objectivity, continuous learning and constructive collaboration.
  • A valid/clear driver's license is required.

About Southwest Research Institute (SwRI)

Southwest Research Institute (SwRI) is a non-profit research and development organization headquartered in San Antonio, Texas. The institute was founded in 1947 and has since grown to employ over 3,000 people across multiple locations in the United States. SwRI provides research and development services to a variety of industries, including automotive, aerospace, and energy. The institute's research areas include automation and data systems, chemistry and chemical engineering, and space science and engineering. SwRI has a long history of working with government agencies, including NASA and the Department of Defense, as well as private companies.
Learn more about Southwest Research Institute (SwRI)
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