Quality System Associate
Oakland-Fremont-Pleasanton Metro Area, CA
Assists in implementation of SAP and ETQ systems.
Assists to maintain processes/procedures to ensure compliance to internal and external requirements.
Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations to assure regulatory compliance and appropriate business planning.
Provides support to carry out the creation, review, revision, approval, release and implementation of change orders within the Document Control System.
Maintains document archival for quality systems and documents.
Assists in the monitoring of the equipment temperature monitoring system.
Reviews equipment certificates of analysis to confirm they meet established criteria.
Performs investigations under the nonconformance process.
Participates in and where necessary drives the continuous improvement of the quality processes.
Helps monitor work to ensure quality, and continuously promote Quality First Time.
Internal support for review of policies and procedures to ensure compliance with international Quality System Regulations (QSR) ISO 9001.
Performs internal audits as needed.
Performs quality review of products as needed.
Understanding of quality philosophies, principles, and systems.
Strong interpersonal and organizational skills.
High degree of initiative with the ability to work independently.
High degree of accuracy and quality.
Basic understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
Basic understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
Ability to work in fast paced setting and cross-functionally with all levels of employees.
Ability to plan and organize work while remaining flexible.
Ability to plan, control and assure product and process quality in accordance with quality principles which include product and process validation, planning processes, material control, acceptance sampling, and measurement systems.
Knowledge of word processing and spreadsheets.
B.S./B.A. in biological or life science, engineering or related field or combination of education and relevant work experience required.