Naomi Peterson39 Walsh Rd. New Ipswich, NH 03071

Phone: (603)903-9105 Email: naomimay2015@yahoo.com

Summary: Accomplished Quality Engineering professional with over 10 years’ experience in FDA 21 CFR parts 210, 211 and 820/ISO 9001, 13485 regulated medical device manufacturing environment. Solid record of collaboration with Operational teams to establish and implement quality oriented and economical solutions. Greenbelt certified, with the skills to work with minimal supervision, while consistently delivering productive and timely results.

Experience: Quality Engineer IINypro FinPack, Clinton, MA(978-368-6021)January 2016 - Current Responsibilities Include:

o Subject Matter Expert for Automated Product Performance Test Equipment:Engineering ownership of automated test equipment. Review of device testing reports for conformance to product specification and analyzation for data trends and process improvement opportunities.

o Assist in New Combination Product Development and Commercialization:Provide gap analysis for new product proposals. Develop quality system and drive product from Clinical Studies to Commercialization. Write and execute validation protocols, deviations and reports.

o Production Support:Perform investigation for cause of high reject rates in production. Develop and implement corrective actions to improve. Use statistical analysis for assessing product performance data, solving complex manufacturing problems and supporting validation strategies.

o Audit Support:Assist with internal, third party and FDA quality audits. Subject matter expert for production testing. Quality documentation review for conformance to FDA CFR part 210, 211, and 820. Backup for front room scribe.

o Nonconformance Investigation:Investigate and document nonconforming material reports. Analyze data for trends and CAPA initiation. Lead all activities in assigned CAPAs.

o Quality Technician Supervision:Responsible for supervising Quality Technicians daily activities and priorities, time management (using Kronos), setting and supporting goals, and completion of reviews (using Success Factors).

Experience: Associate Quality EngineerTeleflex Medical, Jaffrey, NH(603-532-7706)November 2013 – January 2016 Responsibilities Include:

o Complaint Management:Full ownership of customer complaint process, confirmation of defects, root cause investigation, corrective action implementation, effectiveness verification, trend analysis, and direct communication with the customers.

o Validations and Qualifications:Writing and execution of equipment and process validations including new product development and specification review, Gauge R&R, URS, FAT, SAT, Control Plans, and FMEA.

o Process Improvements:Using tools such as 5S, Fishbone Diagrams, SPC analysis, Capability analysis, DMAIC and 7/9 step project formats to reduce scrap and improve product quality.

o Audits:Have acted as lead and/or SME in Internal Audits, Customer Audits, ISO Audits and FDA Audits.

o CAPA:Full ownership of CAPA process including initiation, development and management of action projects, and establishing and monitoring effectiveness verification.

o NCMRsIdentification and control of nonconforming material, RC investigation, establishing CA and effectiveness verification management process.

Related Projects:o Developed 21 CFR 210 & 211 compliant process for new

pharmaceutical product from 21 CFR 820 contracting material process.

o Performed data cleansing and upload from DOS system to SAP for Calibration system as well as management of module and master data post changeover. Performed data cleansing and upload from Microsoft Word documents to SAP for Incoming Inspection system as well as management of module and master data post changeover.

Experience: Quality TechnicianTeleflex Medical, Jaffrey, NH(603-532-7706)May 2011 – November 2013 Responsibilities Included:

o Providing support to Quality Engineering and Management for validations, customer complaints, quality documentation creation can revision, quality improvement projects, and material inspection, disposition and control.

o Use of gauging equipment for GR&R activities and nonconformance investigation including Laser Micrometers, RAM and Starrett Vision Systems, Calipers, Tensile and Elongation Testing, Gauge Pins, and Dial Indicators.

Related Projects:o Implemented and managed electronic storage system (Papervision)

for manufacturing records resulting in reduced footprint of on-site documentation and increased record accessibility.

o Implemented recycling program for scrapped production material resulting in cost savings of over 100k/yr.

o Reduced visual defect scrap rate for Greenbelt project resulting in cost savings of over 50k/yr.

o Qualified new material vendor with impact on 407 products for cost savings over 250k/yr.

Experience: Documentation Specialist IV, Millipore Corporation, Jaffrey, NH(603-532-8711)November 2003 – May 2011

Responsibilities Included:o Writing and editing medical device manufacturing documents (SOP,

TM, TS, URS, FAT, IQ/OQ/PQ, Batch Records and Flow Charts).

o Previously worked in the Pilot Manufacturing area developing manufacturing processes for new products.

o Started in 2003 as a manufacturing operator.

Courses: Microsoft Word I, II, and III Microsoft Excel I, II, and III Grammar and Proofreading Project Management Greenbelt Currently Enrolled in UMass Amherst

Scheduled to take C.Q.E exam through A.S.Q in April of 2017, currently enrolled in online preparation class

Additional Qualifications: Proficient in Microsoft Word, Excel, PowerPoint, and Visio, Minitab, SAP,

Papervision, and Acrobat PDF Maker and Advanced Editor 8.0, Basic editing in AutoCAD. Have experience with Oracle and IQS.

References: Stephanie Urquhart, coworker, 603-289-7921 Clay Creamer, manager, 603-562-5539 Robert Kadlec, coworker, 603-562-4476 Darlene Wilson, supervisor, 603-209-4023 James Westaway, coworker, 603-801-2110