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Arzu Inci Resume

Arzu Inci

*** ******** *** *** *** San Jose, CA 95126

Cell: 215-***-****, Email: adchda@r.postjobfree.com

Summary:

A skilled Quality engineer with experience in process qualification, root cause & process capability analysis and metrics development and monitoring. Key strengths including statistical analysis to identify improvement opportunities and collaborating with cross-functional, global teams to deliver results. Seeking for a challenging position to provide leadership, operations and quality experience, continuous improvement, and project management skills. Knowledge in SAP and Six Sigma. Experience in medical device, coatings and packaging industries. Permanent resident with Green card holder. Skills

• In depth knowledge of root cause analysis, process mapping and impact assessment

• Knowledge of creating data analysis tables and report findings based on statistical evidence and trending

• Experience in performing and reporting quality investigations including, Nonconformance Reports (NCRs) an CAPA

• In depth knowledge in process qualifications; POQs and PQs.

• Strong documentation skills for customer requirements and regulations including, APQP, REACH, FDA and CLP

• Knowledge of leading internal audits for ISO16949 and ISO13485

• Excellent written and oral communication skills

Trainings

• Project Management Program (PMP), Springhouse, Pennsylvania (2019)

• PDA/FDA Joint Regulatory Conference, Washington, DC (2017)

• Gamma and Steam sterilization in primary pharma packaging, Datwyler Alken, Belgium (2017)

• 6 Sigma Green Belt, DuPont Performance Coatings Mechelen/Belgium (2015)

• SPC/Control Plan, KAScert

• FMEA/PFMEA/MSA, KAScert

• PSM (Process Safety Management)

• Waterborne paint technology for automotive primer and clearcoat, DuPont Performance Coatings, Wuppertal/ Germany (2013)

• Waterborne and solventborne paint technology for automotive basecoat and color matching, DuPont Performance Coatings, Wuppertal/Germany (2013)

Professional Experience

• Quality Engineer II, 10/2018 - 2/2020

DSM Biomaterials – Exton, Pennsylvania

o Support commercial business unit regarding engineering activities for all product lines o Responsible for root cause analysis, process mapping and impact assessments for change control o Create data analysis tables and report findings based on statistical evidence and trending o Review new product drawings and make recommendations for quality requirements o Documentation support to global regulatory affairs and customers in FDA filing

• Projects

o Transfer of Silicon Hydrogel (SiHy) products from Berkeley, CA to Exton, PA o Transfer of Thermoplastic Polyurethane (TPU) products from Berkeley, CA to Exton, PA o Troubleshooting yellowing issue in Aliphatic Thermoplastic Polyurethane (ATPU) production batches o Monitoring and reporting metrics for NCRs, Deviations, CAPAs and Complaints

• R&D Support Engineer, 03/2017 - 05/2018

Datwyler Pharma Packaging – Pennsauken, New Jersey o Technical support to healthcare business unit and operations in US o Documentation support to global regulatory affairs and customers in FDA filing o Member of the project team establishing cGMP to the labs o Responsible for safety code determination for the plants in US o Internal auditor for ISO15378 certification

Classified Personnel Informa on

Arzu Inci Resume

• Projects

o Troubleshoot discoloration issue in white rubber stoppers for insulin application o Shelf life determination for in-house steam sterilized products o Evaluation of chlorine dioxide sterilization for elastomeric components o Optimizing packaging components to improve the stability of Epinephrine o Contribute implementation of “Quality by Design” approach to Datwyler Pharma Packaging o Lead benchmarking efforts to define competitive landscape for rubber stoppers

• Senior Technology Engineer, 01/2016 - 07/2016 (Left the position to join my family in Philadelphia, PA) Colgate-Palmolive Company – Istanbul, Turkey

• Responsibilities

o Technology transfer to the local production plant from global R&D Centers (US, India, and Mexico) o Collaborate with quality and production departments to address quality problems in the plant o Alignment of new products to production lines

o Cost improvement of formulations by material simplification and harmonization o Providing necessary documentation to sales, regulatory affairs, quality and production teams

• Technology Engineer, 08/2012 - 12/2015

DuPont Performance Coatings– Istanbul, Turkey

• Responsibilities

o Technology transfer to the local production plant from global R&D Centers (Germany, Belgium, Austria, and US)

o Collaborate with quality and production departments to address quality problems in the plant o Alignment of new products to production lines

o Registration and alignment of new raw materials, resins and dyes o Internally auditing the departments for ISO9001 and ISO16949 certification o Management of lean projects to provide continuous improvement for products and processes o Alignment of new products to production lines and scale up o Visiting customer sites to fulfill specific requirements and address quality complaints o Cost reduction by performing material simplification and harmonization in recipes o Providing necessary documentation to sales, regulatory affairs, quality and production teams

• Process Engineer, 11/2011-07/2012

ASAS San. Tic. A.S.

• Responsibilities

o Responsible for mixing unit operations and planning o Management of 5 employees working in 3 shifts in mixing unit o Management of two European key accounts; Schueco (Germany) and Alphacan (French); organize work flow for all orders, production and shipping

o Monitoring and maintaining raw material stocks in coordination with purchasing department o Supporting Quality Control for client complaints o Arrangement of regular meetings with material suppliers to find cheaper or higher quality alternatives o Supporting quality assurance audits of TSE, RAL, CSTB Professional Preparation

• Master of Science, Polymer Science and Engineering, 09/2009-11/2011 Middle East Technical University, Ankara, Turkey (M.S. advisor: Ahmet M. Onal) Preparation of novel fluorene and furan containing conductive polymers Published 1 first author paper

• Bachelor of Science, Chemistry, 09/2004-05/2009

Middle East Technical University, Ankara, Turkey

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