Contract position: An American multinational biotechnology product development company who is a leader in genetic testing and precision laboratory equipment markets is currently seeking a Quality Engineer in the Millersburg, PA. This is a 1-year CONTRACT position. No per diem available. Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- 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.
- Bachelor's degree in engineering or science related field. 2+ years of quality or engineering experience.
- Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485). Ability to understand various manufacturing processes.