- Design History Files transfer and maintenance, remediation to company requirements and maintenance for these products, including preparation of the Lifecycle Management Systems requirements.
- Design transfer, including product/process validations.
- Support improvements to processes at current Contract Manufacturer pending transfer to the site.
- Emphasis on detecting design defects / process issues to minimize the impact to cost and schedule, and enable the implementation of appropriate controls/ specifications.
- Review, approve, and manage documents, e.g. validation protocols, SOP's, specifications for accuracy and completeness; generate/revise documents as needed.
- Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance.
- Participate in continuous improvement initiatives such as QLP, BioScience Operating Systems, Lean and Six Sigma.
- Track and trend department metrics and quality indicators.
Joining this fast-paced and cutting-edge company will allows you to work with the best in the field. This company is offering a competitive rate for this contract to hire role. Please be in contact as soon as possible.
- Quality assurance engineering experience of technology transfer.
- General working knowledge in continuous improvement tools is preferred.
- Strong working knowledge in project management tools and methodology.
- Experience in the area of design input/output review, design validation, design transfer, and Design History Files creation and management within medical devices is preferred.
To find out more about Real please visit www.realstaffing.com
Real - 2 years ago