Quality Management

*** ******** *****, *** ****, Ca *********@*****.*** 408-***-****

Vicki Kaur

Professional Objective:

A position in quality management providing the opportunity to make a strong contribution to organizational goals through continued development of professional skills

Professional Experience

PerkinElmer (Temp) July 2011-Current

Quality EHS Auditor

• Implementation and monitoring of Environmental Management Systems (ISO 14001and OHSAS 18001).

• Combine ISO 9001 and ISO 14001 Systems

• Create and establish Standard Operating Procedures

• Review and Write Nonconformances, CAPAs and Change Controls

• Compliance Audit Standards to ensure compliance w/ Federal, State, & other regulatory

• Conduct supplier/vendor audits

• Lead, review, manage, investigate and close existing CAPA

• Perform internal audits for compliance to ISO 13485:2003 and FDA 21 CFR 820

• ERT Member

Macu Sight, Inc April 2005-Feb 2010

Quality Systems Specialist II

• Review supplier quality management system

• Ensure compliance to quality management system and regulatory requirements by conducting audit activities under the guidance of the lead auditor,

• Review and ensure incoming materials for packaging, labeling, etc

• Conduct QA duties of the manufacturing floor to monitor and ensure GMP compliance

• Conduct detailed investigation on returned products

• Prepares detailed assessment reports on observations and findings to present to management.

• Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions

• Drive corrective actions for supplier process by using the five whys, determining root cause, completing corrective and preventive actions.

• Initiate nonconformance reports (NCR’s) for all nonconforming material

• Conduct internal audits of the environmental, manufacturing and cleanroom groups

• Present customer complaints, audit findings and defects to management team Interface with Supplier to track performance and corrective actions

• Perform internal audits for compliance to ISO 9001

• Support external audits by customer, FDA and ISO

• Draft audit summaries and report of findings from internal audits performed.

• Data entry, data trending, notebook recording and quarterly reports of test results to internal groups.

• Create and revise company’s standard operation procedures

• Approve ECO according to quality management system

• ERT Member

Read Rite June 2004-April 2005

QA Specialist I

• Initiate, review and approve existing and new CAPAs and coordinate revision with other internal groups

• Revise SOP to reflect new changes in quality assurance and manufacturing

• Perform root cause analysis returned media devices

• Writing and revising Standard Operating Procedures (SOPs) to meet ISO and compliance requirements

• Support external audits by customer, ISO and quality suppliers according to the company standards.

• Document all customer complaints

• Conduct quality meetings to discuss customer concerns and complaints

• Close customer complaints with investigation and corrective actions.

• Monthly presentation to management on open CAPA, customer complaints and corrective actions.

• Batch record review and revise

• Provide quality management system training to new hires

• Member of process improvement team

• ERT Member

Education

Bachelor of Science in Industrial & Systems Engineering, 2004

Minor: Business Management, 2004

Institution: San Jose State University

MBA Master of Business Administration-2007

Institution-University of Phoenix

Auditing Certification

Institution- UC Extension

MS-In Process

Professional Association

Certifications:

Disastrous and 40 Hour Hazardous training certified, Quality Internal Assessor Certified ERT, AED, CPR, MERT and FIRST AID certified. ISO 9000, 140001 and OSHAS 18000 Internal Auditor certified.

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