Quality Assurance Management

Gretchen Campise

***** **** **., ******, ***** **484 832-***-**** email: ad0vcc@r.postjobfree.com SUMMARY

Experienced Quality Assurance professional with twelve years of experience in: implementing and supporting Quality Management Systems through auditing, document control, and designing and conducting training at all levels of the organization. Maintaining company compliance by being the subject matter expert on regulatory and international standards, Corrective and Preventive Actions, and Root Cause Analysis, as well as continuously improving processes. As a Certified Lead Auditor of ISO 9001:2015 and Quality Management Systems through Exemplar Global I have proven my ability to implement, maintain, and support quality management systems to company compliance.

HIGHLIGHTS

● ISO 9001:2015 Certified Lead Auditor; Quality Management Systems Certified Lead Auditor

● Implement and support Quality Management Systems

● Develop internal quality audit and training programs

● Lead organizational compliance to state and international quality standards and regulations

● Documentation and technical writing skills to create quality manuals, SOPs, work instructions, and internal forms

● Decrease non-conformances and improve processes through Corrective / Preventive Action, Root Cause Analysis, including 8D, and Kaizen events

● Support senior management by providing subject matter expertise through interpretation of standards, regulations, and requirements

WORK EXPERIENCE

Quality Assurance Specialist November 2021 to Present G-CON Bio – College Station, Texas

● Implementation of ISO 901:2015 Quality Integrated Management System (QMS / IMS)

● Maintain company compliance to ISO 9001:2015 standard by developing an audit program.

● Conduct and lead internal Audits; support external and third-party audits; conduct supplier audits

● Improve product quality through leading Corrective and Preventive Actions including Root Cause Analysis

● Support senior management by providing Interpretation of standards and requirements thereby ensuring compliance throughout all levels of the organization

● Encourage process improvement through project retrospectives and lessons learned

● Review documentation for compliance to standards, regulations, and customer requirements Quality Assurance Specialist November 2019 to August 2020 Regate Technology, Inc. – Plantersville, Texas

● Improved the Quality Compliance by making recommendations dictated by ISO, API, and Customer Standards and requirements

● Prepared for and participated in third party compliance audit to ISO 9001:2015 Standard

● Improved Document Control System through review, updates, and organization of quality records Quality Control and Compliance Manager June 2018 to February 22, 2019 Evolution Building Systems – Navasota, Texas

● Improved the Quality Management System by reshaping the quality manual to incorporate effective programs and metrics which increased efficiencies and improved product quality

● Established an audit program to lead compliance to state regulations and International Building Codes

● Initiated a training program for production employees and supervisors including Corrective and Preventive Actions using Root Cause Analysis

Quality Assurance Technician September 2011-October 2017 Trinity Heads, Inc. – Navasota, Texas

● Scheduled and implemented an internal audit program focusing on assuring ongoing compliance to AAR M-1003 and ASME Boiler & Pressure Vessel Code, closing internal gaps, and identify any needs for new Quality Management System documents

● Implemented Corrective and Preventive Actions, independently, and through team oversight, to close compliance gaps detected from internal and external audits and quality data analysis

● Maintained and continuously improved the Quality Management System documentation

● Determined the need for training programs, developed, and managed the training materials for all employees including upper and middle management

● Prepared, and when required, led the annual Management Review

● Contributed to the continuous improvement of the Quality Management System by collecting and presenting data regarding rework, defect tracking, and root cause analysis metrics TRAINING

Certified ISO 9001:2015 Lead Auditor – BSI 2022

Internal Auditor – BSI 2022

Residential Inspection – International Code Council – 2018 API Spec Q1 9th Edition - Qualified Specialist, Int’l - 2015 Designing Learning - ASTD Education - 2014

M-1003 Lead Auditor Training - Association of American Railroads - 2013 Introduction to Quality Management - ASQ– 2013

FMEA for Beginners - Quality WBT– 2013

Cost of Quality Implementation - ASQ Management Systems, Inc. - 2013 ISO 9001:2008 Certified Internal Auditor Training - AQS Management Systems, Inc. – 2013 Root Cause Analysis - ASQ - 2013

M-1003 Basic Auditor Training - Association of American Railroads – 2012

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