12 Apr
Quality Assurance Analyst
California, San diego , 92121 San diego USA

Vacancy expired!

RESPONSIBILITIES:Kforce has a client that is seeking a Quality Assurance Analyst in San Diego, CA.Summary:Under minimal supervision, this role carries out the complex daily operations related to of the non-conformance function in Quality Assurance. This role assists departments through the non-conformance and CAPA processes using established procedures. Essential Functions: Manage complex Non-Conformance and Corrective Action/Preventive Action (CAPA) reports Ensure completeness of the non-conformance and CAPA files Assist internal customers with preparation of complex non-conformance and CAPA forms Utilize JDE to perform transactions and verify product information Prepare metrics for weekly trending report and monthly management review meetings Develop and issue Trend Codes for complex non-conformances Assign, review and conduct complex investigations regarding non-conformance trends Assist in training junior personnel Provide support for internal and external audits Carries out duties in compliance with established business policies Perform other duties & projects as assignedREQUIREMENTS: BS/BA degree or equivalent in related field required 3-5+ years of related experience required, in a high volume manufacturing environment preferred Working knowledge of Quality Assurance in a medical device manufacturing environment required, preferably in-vitro diagnostic Knowledge of Quality System Regulations required Advanced skills in MS Office required, and Master Control and JDE preferred Must be detail-orientated, self-motivated and available for flexible scheduling Strong verbal and written communication, problem solving and detail oriented Carrying out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies Understands and is aware of the quality consequences which may occur from the improper performance of their specific job Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activitiesKforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Vacancy expired!


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