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Quality Control Engineer

EnIn Systems
Texas, TX Full Time
POSTED ON 4/22/2025 CLOSED ON 4/24/2025

What are the responsibilities and job description for the Quality Control Engineer position at EnIn Systems?

Key Responsibilities:

  • Perform in-process, final product, and raw material inspections to ensure conformance to specifications.
  • Conduct analytical and functional testing using standard instruments and documented procedures.
  • Maintain accurate quality records, including test results, deviations, and non-conformities.
  • Work with the production and engineering teams to identify, report, and resolve quality issues.
  • Participate in CAPA (Corrective and Preventive Actions), root cause analysis, and problem-solving activities.
  • Support internal and external audits by preparing documentation and assisting with inspections.
  • Ensure adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Review and update Standard Operating Procedures (SOPs) and work instructions.
  • Monitor quality metrics and participate in continuous improvement initiatives.

Required Skills & Qualifications:

  • Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field.
  • 2 years of experience in a Quality Control or Quality Assurance role.
  • Knowledge of quality standards such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820.
  • Experience using laboratory equipment such as pH meters, spectrophotometers, HPLC, etc.
  • Strong analytical, documentation, and communication skills.

Preferred Qualifications:

  • Experience in pharmaceutical, biotech, food, or medical device industries.
  • Working knowledge of LIMS, SAP, or electronic QMS tools.
  • Certification in CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is a plus.

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