We are looking for ??Medical Device - Quality Engineer III for our client in Irwindale, CA
Job Title: Medical Device - Quality Engineer III
Job Location: Irwindale, CA
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
?US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.?
- Responsible for development, implementation and support of product escalation, Risk Management Board (RMB) and Quality Review Board (QRB) processes for BWI.
DUTIES & RESPONSIBILITIES:
- Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- The individual will work under limited supervision to make compliance decisions to meet departmental and internal/external customer needs.
- She/he will coordinate Risk Management Board and Quality Review Board (QRB) activities - coordinate RMB activities, write meeting minutes, route and verify document review are also included duties.
- This individual will be responsible for reporting on escalation metrics to appropriate review boards such as Management Review, CAPA Review Board, Q&C Dashboard, etc.
- This individual will serve as a Team Member of the Product Escalation and Field Action Management Team in order to coordinate with the Field Corrective Action Lead to ensure hand off/transition of QRB actions and documentation that the Field Corrective Action Lead will use to report to regulatory authorities.
- The individual will facilitate root cause investigation, documentation, corrective action recommendations, and project management on RMBs; initiate and or approve document change orders as applicable for job; provide periodic reports, completes special assignments, assists manager as requested; and lead and participate in cross-franchise teams as directed by manager.
- Otherresponsibilities include, but are not limited to: coordinate and participate in special projects as assigned; act as backup support for Field Corrective Action Lead; and act as backup support for other CSS Product Escalation Quality Engineers.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
- Bachelor of Art or Science Degree in Science Field is required.
- Minimum of 4years in medical device manufacturing or related industry experience is required.
- Prior experience in ISO13485 and or QSR 820 FDA regulated environment is desired.
- Excellent interpersonal relations and communication skills are required.
- Advanced skills on Microsoft Office software, including PowerPoint, is required.
- This position is located in Irwindale, CA and requires minimal travel.