Quality Engineer Manager
Resume:
Rosana Hicks
Pueblo West, Co ***** ****.********@*******.*** Cell: 719-***-****
Career Objective
Keen to apply entirety of skills, knowledge and work ethic into challenging role, with Quality Assurance Management of self-development and a professional aptitude. A conscientious and dedicated individual with comprehension and a passion for quality procedures and implementation of internal, and continuous improvement.
Professional Skills:
Certified Auditor for FDA Regulatory Ind.
Product Failure Mode Effect Analysis
Process Control Plan
Test Method Validation/MSA/GR&R
Statistical Analysis (Minitab)
Microsoft Office
6 Sigma Technique
Supplier Quality requirements
Process Improvement
Risk Management
Engineering Change Control
Product Validation Plan
Software Validation
Process Validation: IQ PC OQ PQ
CAPA, NI, ISO 13485, ISO14971 ISO9001,
Quality Management
Project Management
Supply Chain Management
KAIZEN, 5S, 6S, 5 WHYS
Customer Service
Robar Printing Label Software
Industry-Related Experience
Biomedical Innovation-Colorado Springs, CO- Sep 2015- Sep 2018
Senior Quality Engineer:
Lead risk management activities across the program by identifying technical and programmatic risks, analysing mitigation costs and strategies, and helping implement them within the program.
Quality Data Review- (KPI’s) Trending reports for CAPA, NI, Implement PFMEA, Process Control Plan, Product Validation Plan, Development Plan, Test Method Validation, MSA/GR&R (Variable and Attribute Data).
Conduct and review of product validation process such as IQ, PC, OQ, PQ.
Written SOPs, protocols, completion reports, and work instructions.
Supplier Summary Requirements- for component qualifications.
Conduct training for human error, cGMP, Fishbone Analysis, 5 whys, Nonconforming Investigation using PowerPoint.
Review schematics and customer requirements for each product to assure accurate tests are being performed for each product.
Focused on quality and yield improvements through the use of KPI's in conjunction with lean techniques such as 5s (6s including safety), mistake proofing, visual standard work, value stream analysis
Execute process validation and perform Test Method Validation.
Calibrate products to meet client specifications.
Verify functional requirement on new product designs.
Medtronic, Mystic Ct: Sep 2014- Dec 2015
Senior CAPA Compliance Specialist:
Provide NCMR, CAPA metrics for quality management review monthly and quarterly.
Maintain the CAPA and Audit databases records and notify the appropriate owners to assure completion of records in timely manner using TRACKWISE Software system.
Perform queries/reports of business system data base using TRACKWISE utilizing multiple software tools and prepare “Adhoc” and routine reports to support database activities.
Medtronic, Mystic CT:
Quality Engineer:
Developed and conduct machine validation: CSV, PC, IQ, OQ, PQ.
Developed and implemented FMEA, Fishbone Analysis, ECO, RCA, and RMA.
Quality Audit (Internal/External).
Compile and report any unusual conditions or high-risk results that could affect the quality and even safety of the product to leadership using Excel.
Understands how to read and interpret schematics, installation sheets,
and bill of materials and skills to work with several departments, including engineering and production.
Phoenix University, Boston MA- July 2010- August 2013
Project Manager/ Assistant Teacher:
Oversee IT team developers in implementing of a new project life cycle.
Planning and organizing and control the execution of all project activities.
Assembled project plans and teamwork, directing and monitoring work efforts on daily basis.
Montrose-Hauser, Lincoln, RI – Jun 2011- Aug 2012
Quality Manager:
Oversee all aspects of QC/QA for Montrose products, including manage QA/QC inspectors.
Monitor and advised on the performance of the QMS, QSR, CAPA, NCMRs, and Deviations.
Ability to drive quality and yield improvements through the use of KPI's in conjunction with lean techniques such as 5s (6s including safety), mistake proofing, visual standard work, value stream analysis
Conducted continuous improvement through removal of waste.
Ability to work with the production and maintenance groups to increase yield through quality improvement methodologies
Implement automation and process control projects where necessary to improve product quality and personnel safety
Developing monitoring and refining process control practice
Proven Process Medical Device, Mansfield, MA- Apr 2008- July 2010
Quality Engineer:
Developed and conduct machine validation: CSV, PC, IQ, OQ, PQ.
Quality Audit (Internal/External) and EU MDR Compliance
Implemented software Validation for the iCAD mammogram units, Syncardia and MRI systems.
Discovery 777, Coventry, RI-Aug 2006- Apr 2008
Marketing Director /Supplier Chain Manager-Air/Water Purification System (Ecoquest)
Managed Sales and Recruiting staff.
Managed of supply chains, supply chain professionals coordinate production among multiple providers.
Stryker Biotech, Hopkinton, MA- Apr 2003- Jun 2006
Quality Engineer:
Responsible for reviewing QC Assay data, Technical reports, Equipment records.
Review all batch records and reports, closing CAPA, NCMR, Customer Complaints, ECO and Deviations.
Quality Audit (Internal/External).
Technical support with customers, suppliers, aid for technical report for outside testing.
Education & Certification
Bachelor of Science Degree in Information Technology/Concentration: System Security, University of Phoenix
Applied Science in Chemical Technology-Community College of Rhode Island.
Certification:
2017 Internal Auditor Training for FDA Regulated Industries (ISO 13485:2003, 2016)
ISO 13485:2003 Requirements Training
Corrective Preventive Action Workshop
Process Validation Workshop/ AAMI
Risk Management Workshop
Incident Investigation/Root Cause Analysis
Database Fundamentals, MYSQL
Oracle Database 10g: Monitoring and Managing Performance and Storage
Computer System Validation
Fundamental of MySQL
Software Life Cycle Models
Software Testing
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