Quality Assurance Specialist
Department: Quality Assurance
Reports To: Director of Quality
Posted On: 2/3/2010

SUMMARY
To provide support to maintain the Quality System in accordance with US FDA Quality System Regulation, ISO 13485 and ISO 9001. Provide input and follow-up on NCMRs, CAPAs, investigations, validations, calibrations, environmental monitoring, training, Customer Complaints, Audit Reports, and distribution activities; and provide administrative support within the Quality Assurance Department. To perform QC checks to support operations and incoming materials.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Review and process controlled documents
  • Maintain Quality Records
  • Update/Maintain Quality Databases
  • Close & Review open LHRs, Perform Product Release
  • Publish Audit Reports (Internal and External)
  • Maintain the CAPAs, Complaints, Calibration & Audits Systems.
  • Provide support to QC function that performs incoming and in-process inspection of product
  • Assist QA Director, QE and QA Manager with special projects
SUPERVISORY RESPONSIBILITIES
Direct Reports: None

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Good understanding of US FDA GMP (Good Manufacturing Practices) knowledge and experience
  • Previous experience in Medical Device Field (ISO 13485) a plus
EDUCATION and/or EXPERIENCE
2 Year Degree or 1- 4 years work experience in Quality Assurance and/or Quality Control. References required

SYSTEMS TECHNOLOGY SKILLS
Knowledge in utilization of Microsoft Word, Excel, Outlook, Access, and Internet applications.

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Please submit your resume with cover letter to:

Cytori Therapeutics, Inc.
Human Resources Department
3020 Callan Road
San Diego, CA 92121
USA

Tel: +1.858. 458.0900
Fax: +1.858.458.0994
Email: jobs@cytoritx.com