Immediate Need Q A with QARA Medical device manufacturing background
Experience Must {Interview ASAP}
Position : Q A with QARA Medical device manufacturing background
Experience Must
Location : Brooklyn Center MN
Duration : 6-12 Months
Skill Experience Must
Process Validation, IQ, OQ, PQ
Responsibilities:
5-8 years experience
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, measuring 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.
*Roy, Sr Recruiter*
*LiveMindz*
*8330 LBJ Fwy, # B 682 , Dallas, Texas 75243*
*www.livemindz.com <http://www.livemindz.com> | [email protected]
<[email protected]>*
*D/L : 972. 525.4161 | F : 972.534.6388*
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