Hello,
Please go through the job description and let me know the interest.
Reply me at richa.s@itscient.com
Role: QA Analyst with Medical Devices Exp
Location: Mounds View, MN
Duration: 6+ Months
Job Description:
Prior medical device manufacturing background and experience required.
Experience in Test Method Validation and execution, Experience in TMV /Gage R& R and incoming inspections and related procedures.
Experience in Receiving Inspection. Use of statistical Tools for Analysis such as Minitab etc.
Process validation working knowledge, writing the test cases of IQ/OQ/PQ protocols and execute the same in production environment.
Ability to review all the protocols of IQ/OQ/PQ and provide suggestions/solutions.
Manage the execution of validation protocols and write summary reports, etc., in assurance of timely and cost efficient completion through specialized experience and training as necessary.
Ability to review Specifications /documents /Drawings , Details Data collection Reliability Test plan /protocols creation/ Execution Hazard Analysis / Component Design FMEA / review /verification / Updation Track the results with CAPA Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills. Process validation and working in a clean room environment and use of inspection, easuring and testing equipment.
Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary. Communicate significant issues or developments identified during production, validation and qualification activities.
Evaluate validation results of validation protocol executions employing specialized experience and training. Ensure validation efforts are conducted in an appropriate and timely manner. Ability to make independent decisions and successful track record of influencing key stakeholders.
Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team. Knowledge on ISO 13485/Part 820 / ISO 14971 will be preferred.
Thanks and regards,
Richa Sharma
|| IT-SCIENT || Phone: 510.870.5083 || Fax: 877.701.4872 || Email: richa.s@itscient.com || Web: itscient.com ||
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