/Quality Engineer I (Entry-Level / Regulatory Focus)

Quality Engineer I (Entry-Level / Regulatory Focus)

Sumter, SC, USusvia direct
// Job Type
Full Time
// Salary
USD 37 - 37/hour
// Salary Range
37.04–37.04 USD / hour
// Posted
1 month ago

About the Role

A-Line Staffing is now hiring Quality Engineer I (Entry-Level / Regulatory Focus) in Sumter, SC. The Quality Engineer I (Entry-Level / Regulatory Focus) would be working for a Fortune 500 company and has career growth potential. This would be full time / 40+ hours per week.

If you are interested in this Quality Engineer I (Entry-Level / Regulatory Focus) position, please contact Lindsay at 5867107959 or LKOPASZ@ALINESTAFFING.com

Quality Engineer I (Entry-Level / Regulatory Focus) Compensation

  • The pay for this position is $37.04 per hour
  • Benefits are available to full-time employees after 90 days of employment
  • A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates

Quality Engineer I (Entry-Level / Regulatory Focus) Highlights

  • This position is a contract assignment with potential to hire on permanently based upon attendance, performance, and business needs
  • The required availability for this position is Monday–Friday, standard business hours (8:00 AM – 5:00 PM, some flexibility)

Quality Engineer I (Entry-Level / Regulatory Focus) Responsibilities

  • Support product and service quality evaluation and control activities
  • Work cross-functionally in the development and maintenance of products and processes
  • Assist in resolving equipment- and process-related production issues
  • Participate in equipment, process, material, and method validation activities
  • Conduct statistical analysis and interpret metrics to evaluate systems and processes
  • Apply basic knowledge of FDA/ISO and cGMP regulatory requirements
  • Develop and execute test protocols, collect data, and generate validation reports
  • Perform root cause analysis using tools such as Fishbone Diagrams
  • Support complaint investigations and remediation activities
  • Utilize systems such as TrackWise and SAP for documentation and tracking

Quality Engineer I (Entry-Level / Regulatory Focus) Requirements

  • Bachelor’s degree required (Engineering or related field preferred)
  • 6 months to 2.5 years of relevant experience
  • Basic understanding of quality engineering principles and best practices
  • Experience with regulatory standards (FDA, ISO, cGMP)
  • Proficiency in Microsoft Excel (macros preferred)
  • Strong written and verbal communication skills
  • High School Diploma or GED
  • Attendance is mandatory for the first 90 days

Quality Engineer I (Entry-Level / Regulatory Focus) Preferred Qualifications

  • Experience with TrackWise, SAP, and/or Minitab
  • Knowledge of root cause analysis methodologies
  • Exposure to statistical analysis and validation processes

If you think this Quality Engineer I (Entry-Level / Regulatory Focus) position is a good fit for you, please reach out to me - feel free to call, e-mail, or apply to this posting!

 If you are interested in this Quality Engineer I (Entry-Level / Regulatory Focus) position, please contact Lindsay at 5867107959 or LKOPASZ@ALINESTAFFING.com

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