Quality Assurance Specialist I

The position of Quality Assurance Specialist I is within our CMI Unit located in Pomona, California. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control.

WHAT YOU’LL DO

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations.
• Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).
• Assist in determining quality attributes and requirements. May provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Work with managers to coordinate training requirements for employees as required.
• Manage training program and organizational chart as required.
• Perform Quality System Training Requirements as needed.
• Review/approve supplier surveys and make recommendations as required.
• Assist with internal audits and agency audits.
• Manage Document Control as required.
• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Manage equipment maintenance and calibration program as required.
• Assist with equipment, process and facility qualification and validation activities as required.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• 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 activities.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Perform other duties and projects as assigned.

Required Qualifications: