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Post Market Quality Assurance Coordinator I


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Job Title :Post Market Quality Assurance Coordinator I
Job Id :5443
Location :Pleasanton CA 94588
Duration :2 months

Summary Position:
Review and perform follow up activities on all product complaints relative to the identity, quality,
reliability, safety and effectiveness of medical devices.

Essential Functions:
(1) Performs follow up activities to obtain additional information after an evaluation of incoming
complaint has been performed.
(2) Use and maintain database(s), may provide analysis on complaints.
(3) May identify and document appropriate complaint categories to assure trend accuracy within the
complaint database.
(4) Ensures record documentation is maintained in a constant state of audit readiness per internal
policies.

MINIMUM REQUIREMENTS:
Education required/preferred Bachelors degree in relevant field preferred (i.e. engineering, life
sciences).

Experience:
Preferred 1 to 2 years quality assurance or regulatory experience in medical or
pharmaceutical industry. Experience in Post Market Surveillance (complaint handling) preferred.
Individual with a suitable college degree or other relevant experience may qualify. Experience with Good
Documentation Practices (GDP).

Skills/Competencies:
Computer literate with skills in Word, Excel, Access, PowerPoint a preference.
Ability to communicate effectively in oral and written formats. Ability to type. Ability to work in a team
oriented environment. Ability to multitask. Ability to use office equipment (copier, fax machine).

Preferred Skills:
Basic knowledge of medical devices, their development and quality control.
Maintains central, controlled supply of classified and unclassified documents originating within an organization. Reviews documents to determine pre-established classification level based on contracts or security manual, distribution requirements and processes distribution requests according to established procedures. Ensures generation of quality assurance checklist for product release packages in support of production schedules. May be required to maintain a secure, computerized document revision system, a periodic review system, and status tracking for all process-related documents and records.

If you are interested in this position then you can reach me at 2015249600 X 7944

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