Opening for an Quality Assurance Specialist (Vista, CA)

SNAPSHOT!

Looking to join a pioneering biomedical compant that works with leading research institutes and universities to develope breakthrough technologies? READ ON!! Our client is seeking an experienced and motivated Quality Assurance Specialist with a strong background in medical device manufacturing. The successful candidate will report to the Sr. Director Program Management, Quality Systems and Compliance and work with the team to maintain and manage the quality management system. Knowledge of cGMP, GLP, ISO regulations are a plus.

Immediate Opening for Quality Assurance Specialist in Vista, CA who possesses:

• BS in engineering, technical, or science field

• 3+ years of work experience in medical device or biotech manufacturing with good understanding of current Good Manufacturing Practices

• Knowledge of ISO 13485, 21CFR820

• 1+ years supporting ECO’s, NCR’s, CAPA’s

• 1+ years supporting audits

• 2+ years in Document Control

• MS Word and Excel - basic to intermediate skills

• Be an independent, self-starter with exceptional communication (written and verbal) skills, detail oriented, organized, and able to prioritize and balance department workloads in a fast-paced environment

• Demonstrated evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels

• Must be available to work hours outside of normal workday as needed

• Experience with electronic quality management systems software a plus

Key Responsibilities include:

• Support Quality System processes in compliance with ISO 13485, 21CFR 820, applicable regulatory requirements and Quality Policy

• Support Gowning area environment monitoring

• Support supplier qualification, and supplier corrective actions (SCAR) processes

• Assign and manage CAPA’s

• Assist in Complaint handling, NCR’s, and CAPAs/ SCARs

• Assist in audits and publish audit reports (Internal and External)

• Assist QA management with special projects

• Process trending (CAPAs, SCARs, Complaints)

• Provide support to maintain Quality Management System in accordance with US FDA Quality System Regulations and ISO 13485 for controlled documents (paper and electronic)

• Reviews incoming documents for completeness and determines proper filing category for accurate archival, retrieval and record keeping

• Oversee the scanning and upload of documents to the document management system

• Take charge of all document identification, classification, and filing

• Assist internal audits and regulatory inspections through retrieval and coordination of documents

• Routing ECOs, NCRs, CAPAs and various other documents either paper or electronically

• Maintaining correct revision level of documents in control books (paper and electronically)

• Check and edit incoming documents and prepare for distribution

• Support the training program and provide trainings on eQMS and Quality Management System to employees

• Update and maintain Quality Databases

• Support other QA/QC functions such as inspection and testing, nonconforming material processing, etc

• Assist QA management with special projects and other duties as assigned

• Works collaboratively with the team

For immediate consideration, please send your resume to admin@snapstaffing.com!