Over fifteen years of progressive experience in working in and developing documentation for Quality Management Systems for manufacturing environments.
Professional experience
ERA, A Waters Company Golden, CO
An analytical standards and reagents manufacture producing chemical products for environmental, pharmaceutical and clinical environments.
Quality Manager 2012 – Present
Responsible for the maintenance, development and leadership of Quality Management Systems for manufacturing facilities in the UK and USA.
Maintain ISO 9001 certification and ISO 17043, 17025 and Guide 34 accreditation for two manufacturing facilities
Lead Internal Audit team responsible for identifying gaps between Quality Management System and ISO standards 9001, 17025, 17043 and Guide 34
Lead CAPA program by analyzing complaint trends, nonconformances and service data to initiate CAPA, where necessary.
Initiate Supplier Quality corrective actions for vendor-caused nonconformances and perform supplier audits, as assigned.
Ensure that complaint, nonconformance and defect data are reviewed and available for reporting during monthly management review meetings.
Evaluate customer complaints and comments for trends that affect product and process quality.
Provide customer communication for complaint investigation results.
Teach root cause analysis concepts and tools to the organization to drive continuous improvement.
Provide leadership and training in Quality Management System tools and methodologies to staff.
Fulfill role of health and safety officer
Manage the workflow and professional development of two employees
Sorin Group USA, Inc. Arvada, CO
A medical device manufacturer focusing on cardiac care devices.
Quality Engineer 2008 – 2012
Provide Quality support for manufacturing and servicing of Autotransfusion systems, Heart Lung Machines and disposable accessories.
Participate in Internal Audit program by performing audits and responding to observations and findings identified by others.
Audit guide for electrical safety certification audits performed by external agency. Responsible for the response to identified observations and findings.
Responsible for documentation of root cause analysis of complaints.
Support the filing of MDR for all Sorin Group products.
Support the filing, documentation and completion of Sorin Group Field Actions.
Lead international conference call with European affiliates for review of worldwide complaints and quality issues they may indicate.
Project leader to convert nonconformance reporting from a hard copy form to an electronic system.
Participate in CAPA program by analyzing complaint trends, nonconformances and service data to initiate CAPA, where necessary.
Initiate Supplier Quality corrective actions for vendor-caused nonconformances and perform supplier audits, as assigned.
Ensure that complaint, nonconformance and defect data are reviewed and reported during monthly management review meetings.
Manage workflow and professional development of two complaint investigators
GE Analytical Instruments (formerly Ionics Instruments) Boulder, CO
A manufacturer of water quality instruments for use in pharmaceutical, power, semi-conductor and water treatment facilities.
Factory Service Manager 2007 – 2008
Ensure customer satisfaction for repair of instruments returned to the factory for maintenance or repair
Participate on Internal Audit Team
Represent the Aftermarket group on three New Product Development teams
Provide analysis of Customer Satisfaction Survey Data
Maintain physical inventory for parts used in the repair and rework of product
Manage Factory Service/Remanufacturing Assembly department, which consisted of four Service Technicians and two Remanufacturing Assemblers and six technical phone support personnel
Business Systems/Quality Analyst 2002 – 2007
Participant on Internal Audit Team, Performing Minimum Two Audits Annually Locally and Leading an Annual...
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