Pawtucket, RI Posted: 1/8/2019
Quality Engineer - Medical Device - 2nd Shift
- Quality Engineer medical device industry experience
- Strong knowledge in design and development of medical device products
- Experience in Quality System tools and problem solving
- ISO 13485 and QSR/cGMP requirements
- Action plan development and root cause analysis completion of CAPA activities.
- Write and review quality documentation such as procedures, test protocols and reports.
- Coordinate efforts with department leads for the development and implementation of new and updated Quality System procedures and processes.
- Work with department leads in identifying and establishing quality related metrics.
- Apply root cause analysis and problem-solving methods in identifying, prioritizing, communicating, and resolving quality related issues.
- Investigation and processing of product investigations for nonconforming materials
- Development and optimization of current quality processes
- Assist in the development of process monitoring and measurement tools.
- Provide support with Internal & External audit activities.
- IQ, OQ, PQ and Validations to support ISO 13485 requirements
Supplier Qualification, Product Inspection, CAPA, Validation, Management Review and aiding R&D and Manufacturing with product complaints and investigations.
- BS ME/MFG/QE
- 3+ years of experience
- Medical Device
Send resume to:
Search Staffing Group, Inc./Engineering Group
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