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Quality Engineer
Ref No.: 18-17339
Location: Millersburg, Pennsylvania
Skill Type
Skill Type:Engineering

Key Responsibilities:

  • Collect, analyze and present quality data.
  • Establish and optimize test methods and product specifications.
  • Write and conduct validations (IQ/OQ/PQ) for manufacturing processes and equipment.
  • Analyze adequacy of inspection criteria and techniques, recognize critical attributes when establishing validation requirements.
  • Develop and write protocols for new procedures.
  • Review and edit existing procedures.
  • Work with Product Development/Engineering to implement new processes and products.

Minimum Requirements/Qualifications:

  • Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
  • Ability to understand various manufacturing processes.
  • Excellent writing and communication skills.
  • Ability to interface well with others working at all levels.
  • Ability to develop and implement procedures.
  • Ability to perform investigative process as well as critical thinking and problem solving.
  • Knowledge of statistical based computer programs such as Minitab, as well as Microsoft Office.
  • Ability to read and understand CAD drawings.
  • Experience working in a cGMP environment.
  • Experience working in a manufacturing environment

Non-Negotiable Hiring Criteria:

  • Bachelor's degree in engineering or science related field.
  • 2+ years of quality or engineering experience.
  • Ability to understand various manufacturing processes including plastics manufacturing.
  • Excellent technical skills.