Description
Quality Engineer - 6 Month Contract (Potential for Direct Hire) - Medical Device - Twin CitiesMy client, one of the top Medical Device companies globally, has an exciting Quality Engineering opportunity. They are looking for a motivated individual who has a strong background in Validation and Test Method Development.
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
- Determine if data sets meet acceptance criteria
- 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
- Strong understanding of statistics and CPK
- Medical Device Industry 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
If you, or anyone you know are interested, please get in contact with me as soon as possible via email, as all first round interviews will be confirmed by the end of this week!
For Immediate consideration please apply online or contact Jack Feeley at