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Miles
Km80.5

Quality Analyst

AccuMetrics, Inc.

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Location: San Diego, CA Posted Date: 4/30/2013 Position Type: Full time Job Code: 116 MW Required Education: Bachelors Degree Areas of Expertise Desired: Cardiology
Process Development
Quality Assurance
Regulatory Affairs
Validation

Description

In this role you will be responsible for review and closure of inquiries and complaints and for supporting the CAPA system. Review and analyze data and manage documentation as it pertains to the complaint and CAPA programs.  Will track, trend, and report on assigned quality system activities.  Interact with cross-functional groups.  Manage the on-going maintenance of the Complaint and CAPA systems, including tracking, trending, appropriate closure, and effectiveness checks. Chair meetings of the Complaint Review Board (CRB) to review customer feedback and monitor trends. Develop and maintain a variety of metrics pertaining to quality system activities as assigned. Participate in the development of slides/data for Management Review. Provide support to the Change Management program and Document Control activities, including, but not limited to, verification of changes, filing of approved documents, and other duties as assigned. Conduct internal, external (supplier) and/or 3rd party audits.

Act independently with minimal supervision. Accountable for decisions regarding individual quality records and makes recommendations for quality system programs. Has a general working knowledge of all quality system programs.

Requirements

•BS/BA degree with certification in a Quality Assurance discipline.
•Minimum of 5 years experience in a FDA regulated Medical Device, Biotech, or Pharmaceutical organization.
•Clear understanding of and ability to implement QSR regulations (21 CFR Part 820) and ISO 13485.
•Ability to interpret analytical data.
•Strong organizational skills and attention to detail.
•Strong verbal and written communication skills.
•Strong interpersonal skills and ability to work as an effective team member.
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