-Collect, analyze and present quality data.
-Establish and optimize test methods and product specifications.
-Write and conduct validations (IQ/OQ/PQ) for manufacturing processess 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.
- 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.
Non-Negotiable Hiring Criteria:
- 1+ 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.