Harrisburg-Carlisle Metro Area, PA
- 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.
- 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
- 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.