Description
Quality Engineer - 6 Month Contract - Medical Device - MinneapolisMy client, one of the top Medical Device companies globally, has an exciting Quality Engineering opportunity within the Medical Device Industry. They are looking for a motivated individual who has a strong background in Validation and Test Method Development. This is a great opportunity to work on cutting edge Medical Device products.
Responsibilities:
- Process qualification
- Review IQ/OQ/PQ documents from manufacturing counterparts
- Develop test method development and validation protocols to establish acceptance criteria as well as write reports
- Participate in cross functional teams
- Implement and conduct data analysis, system evaluation and product assessment to ensure finished products meet standards
- Ensure compliance to ISO 13485 and 21 CFR 820
Requirements:
- Bachelors in an Engineering field
- Medical device experience
- Strong understanding of Process Validation (IQ/OQ/PQ) - must be able to define this and say why companies do this
- Self starter
- Independent
- Open communicator