Sr Quality System Specialist
Requisition ID 24765
Full/Part Time
Location Valencia, CA
Description Primary Function:
Develop, support and administer one of the Quality System elements.
Position Objectives:
. Perform Quality Assurance (QA) and Regulatory Affairs (RA) support activities as they pertain to Corrective and Preventive Action (CAPA).
. Maintain system as it relates to CAPA.
. Implement changes and improvements to the CAPA System as and when required in order to maintain substantial compliance with Corporate and FDA standards.
. Provide support and implement CAPA projects.
. Bring Boston Scientific Neuromodulation CAPA system into alignment with the Boston Scientific Corporate CAPA system.
Responsibilities:
Responsible for effective management of the following RA/QA process:
1. CAPA management.
2. Document control, including the processing of Corrective Action Requests (CARs), CAPA phases (Investigation Plans, Investigation Results, Implement Solution, Verification of Effectiveness and Executive Summary).
3. Management of quality system records including accurate and timely storage and retrieval of CAPA documentation.
4. Timely processing of CAPA activities including processing, database management and data trending. May be required to present trend data to Upper Management.
5. Interact with Phase owners and Phase sponsors.
6. Present status and overview of the CAPA system to CARB.
7. May be asked to assume ownership of individual CAPAs, as required.
8. Perform review and inspection of phases and final CAPA.
9. Responsible for maintaining CAPA files in a state of continuous compliance and audit readiness.
10. Consolidation of corporate CAPA activities into site CAPA process.
11. Perform other QA/RA projects as required.
Education & Work Experience Qualifications:
. Minimum of five years combined experience in medical device quality and regulatory systems. Good understanding of standard quality control/quality assurance methods.
. Experience working within medical device quality systems including Quality System Regulations (QSR) and ISO 13485:2003.
. Undergraduate degree or equivalent of education and work experience.
. Technical writing ability and presentation skills.
. Strong computer skills, including Word, Excel, and Power Point.
. Detail-oriented.