Quality Assurance Specialist

Company: CyberCoders
Location: Vista
Posted on: February 19, 2021

Job Description:

If you are a QA Specialist with 2-10 years of experience, please read on!

Based in Vista we're a fast-growing pioneering biomedical company working with leading research institutes and universities to develop breakthrough technologies to get people better. We are seeking an experienced and motivated Quality Assurance Specialist with a strong background in medical device manufacturing.

This individual will report to the Sr. Director Program Management, Quality Systems and Compliance and work with our team to maintain and manage the quality management system.

What You Will Be Doing

• Support processes in compliance with ISO 13485, 21CFR 820, applicable regulatory requirements and our Quality Policy
• Support Gowning area environment monitoring
• Support supplier qualification, and supplier corrective actions (SCAR) processes
• Assign and manage CAPAs
• Assist in Complaint handling, NCRs, and CAPAs/ SCARs
• Assist in audits and publish audit reports (Internal and External)
• 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.
  What You Need for this Position
  
  • 2-7 years of experience in document control
  • Bachelor's Degree
  • Experience in medical device or biotech manufacturing
  • Knowledge of ISO 13485, 21CFR820
  • Supporting ECOs, NCRs, CAPAs
  • Supporting audits
  • 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
  • Available to work hours outside of normal workday as needed
    Extra Credit
    
    • electronic quality management systems software experience
    • Knowledge of cGMP, GLP, ISO regulations
      So, if you are a QA Specialist with experience, please email and apply today!
      
      Email Your Resume In Word To
      
      Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
      
      
      • Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : LD4- -- in the email subject line for your application to be considered.***
        Lauren Doversola - Lead Recruiter - CyberCoders
        
        Applicants must be authorized to work in the U.S.
        
        CyberCoders, Inc is proud to be an Equal Opportunity Employer
        
        All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
        
        Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Vista , Quality Assurance Specialist, Other , Vista, California