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Quality Engineer
Ref No.: 18-06571
Location: Millersburg, Pennsylvania
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 environmentNon-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.Ability to travel both domestic and some foreign.