Quality Systems Associate

A Quality Systems Associate job in Valencia, CA is available through Adecco Medical and Science. The Quality Systems Associate Manages and coordinates activities and critical quality systems elements to maintain compliance with and conformance to U.S. FDA, ISO and other applicable regulatory and governmental requirements. Advocates QS best practices though out the organization through example and training.

SPECIFIC DUTIES AND RESPONSIBILITIES:

Assists the Quality Systems Manager in maintaining Quality Management System
Ensures that internal procedures and forms used to implement the Quality Management System are effective and in alignment with all internal and external requirements.
Adopt a metrics/KPI driven approach to measuring and improving quality by setting, monitoring and achieving project quality metrics - develops QMS strategies and inputs to realize overall goal of continuous improvement.
Collects, analyzes and prepares data for Quality and Management Review meetings
Maintains the Post Market Surveillance System for new and existing product lines. This entails the planning of Post Market Surveillance activities and Post Market Clinical Follow-Up strategies, collection and analysis of Post Market Surveillance data, and authoring of annual Post Market Surveillance reports, amongst other duties.
Oversees and maintains Risk Management Process, files, logs and documentation for new and existing products. Updates the Risk Management Files on a periodic basis.
Review/authors Quality System procedures, protocols and reports, supports the development and performance of Quality Systems-related training and participates in internal/external compliance audits.
Assists Software Quality Engineering group with preparation and execution of verification and validation testing protocols
Conducts configuration control of internal and external change requests - logs Engineering Change Requests/Orders from contract manufacturers.
Additional tasks and responsibilities as assigned by department Manager.


EDUCATIONAL REQUIREMENTS:

College Degree and/or equivalent Quality Systems Experience


EXPERIENCE:

Three years' experience in medical devices or related industry - prior experience with regulatory audits is preferred, but not required


KNOWLEDGE, SKILLS AND ABILITIES:

Knowledge of Quality Systems, FDA, EMEA regulations and compliance is expected for this role.
Strong communication skills, both verbal and written.
Attention to detail and good organizational skills Ability to make decisions within established policies and procedures.
Project management/coordination and technical writing experience is highly desirable.
Strong computer skills required especially in Microsoft Office.
ASQ certification is helpful, but not required.
Self-motivated and demonstrates independent judgment within broadly defined policies and practices in resolving problems and making recommendations.


If you are interested in this Quality Systems Associate job in Valencia, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information, please contact Sindie Rothstein at 858-410-1108 or by email at Sindie.rothstein@adeccona.com.

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Reference number US_EN_2_108175_332390