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Quality Engineer

Concord, California, United States
February 17, 2018

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Ben Azadeh

Cell: 925-***-****



Quality Assurance experience, with strong quality systems background in Medical device and Diagnostics industries; Have worked with GQMS, Agile, WindChill, EDMS, ETMS and SAP systems.

Medical device new product development and Design controls.

Product Nonconformance, CAPA Program Management, Root Cause Analysis and Reporting.

Audit and Nonconformance investigations.

Field failure, root cause analysis and reporting, with the emphasis on product improvement.

Have worked with domestic and international medical device standards and requirements (ISO, MDD, FDA, GMP, QSR, IVD, CMDR…); including maintaining Domestic and International Standards, comprehensive gap analysis, their document control and management update.

Familiar with MDSAP requirements.

Have worked on risk management/analysis tasks (FMEA, HA and helped with Risk management plans, reporting, considering ISO 9001, 13485, 14971, 21 CFR, QSR, GMP, MDD and other standards.

Worked with Audit teams and review of audit reports; as well as part of audit team (FDA, TUV, CSA, ANVISA; Also, have been part of CE marking team.

Have reviewed and influenced many product manuals, IFU’s, Quality system manuals, test procedures and reports, SOPs, DHF documents and management reports.

Working with Regulatory on Essential Requirements (ER) and FDA responses.

Have managed Supplier Quality SCARs, in direct contact with suppliers and third parties; Domestic and International.

Career History

Abaxis Global Diagnostics, Union City, CA October 2017 to Dec. 29, 2017

[Multi-panel Chemistry Analyzers, using single use reagent Discs]

(Consultant - Quality Engineering)

Helped with spreadsheet validation protocols and reports, CAPA investigations and Internal Audit Nonconformance root cause analysis, action items and effectiveness check completions.

Assisted response to the Quality Objective Projects, Management Review and action plan items.

Career Search Apr. 2017 to Oct. 2017

During this time, I was searching for a job and a position that could be a good complement to my background and experience.

Personal and Family time off and Job search Sept. 2016 to Mar. 2017

Used some quality time with my family and other personal matters; using my severance and layoff pays.

Fresenius Medical Care [Dialysis Machines], Concord, CA Aug. 2014 to Aug. 2016

Senior Quality System Engineer [Layoffs – Department Closure]

In charge of mitigating and consulting all CAPA related issues; including brain-storming, root cause analysis, reporting, solution identification, implementation, effectiveness checks and monitoring. Tracked CAPA project phases with weekly updates, monthly Management reports & charts and provided relevant Metrics.

Worked with US and European Sites/Suppliers to complete CAPA documentation and gathering objective evidences. Wrote and updated Procedures, as part of CAPA Corrections or corrective actions

Worked with R&D teams, at all levels, on CAPAs at all phases [initiation, investigation, implementation, verification or validation, effectiveness checks, and monitoring activities.

Managed CRB meetings, Helped teams to prepare for CRB reviews and approvals.

Celera Diagnostics (Quest Diagnostics) [Genotyping Products] – Alameda, CA 2011– 2014 [Layoffs – MFG Site Closure] - Senior Quality Engineer

In charge of investigating, mitigating, monitoring and reporting product quality and incoming issues

Managed, Product, Process and Quality System nonconformance programs.

Managed all aspects of nonconformity investigation (Incoming and Manufacturing), product disposition, management reporting.

Supplier Quality team member to track and respond to specific to Nonconformance issues.

Managed the NCP data logs; performed historical data searches, review and reports.

Generated the Quarterly Management Review Board’s NCP Reporting.

Reviewed Quality System Document Changes and made correction recommendations.

Abbott Diabetes Care (ADC) 2010 – 2011

Sr. CAPA Investigator- Contract

In charge of all aspects of CAPA Investigations for the FreeStyle and Navigator glucose monitoring systems

Handled full investigation and root cause analysis of nonconformance and excursion reports, including manufacturing, customer complaints, and internal and external audit findings of both technical and non-technical nature.

Served as quality assurance liaison on the CAPA Review Board; Prepared Validation Review data for Preventive Maintenance reports; Worked on documentation prepared for FDA submission

Novelics [Embedded Memory] 2009 - 2010

Sr. QA Systems (consultant)

Provided review of the quality systems, quality assurance documentation and made necessary gap analysis recommendations.

Cerus Corporation [Intercept Blood System – Pathogen Reduction] 2006 - 2008

Senior QA Systems Engineer - Contract

In charge of maintaining the DHR and DHF documents; The Standards’ update and Gap Analysis; CAPA and Risk Analysis plans, reports and reviews, to enhance blood safety.

Completed a detailed standards’ gap analysis for all products since 1990, with respect to the current ISO and MDD requirements.

Detailed bio-safety analysis matrix and gap analysis, considering both current USP and EP cases, as well as all 10993 (Chemical and physical biological tests).

Reviewed and documented the new Automatic Mixing and Dosing Device (Phase one, Design control); Organized and reviewed the design control documents for Cerus products.

Helped QA and Regulatory to phase-in ISO-13485 certification (TUV) and readiness for internal and TUV audit/s.

MTO Publications Inc. 2003 - 2006

General Manager and QA Officer

Managed the US, Canada Europe and Australia Offices for this non-profit international publication company, with 3 main branches in Europe.

Managed Standards Compliance and Quality Assurance Systems, Documentation and procedures, based on the country specific rules and regulations; Headed sales strategic teams and specific international printing initiatives; Helped negotiations and contracts with Publishers, Printers and distributors in China, Russia, and Europe; Worked with the branch management to set-up London and Frankfurt centers’ quality systems.

Wrote Organizational Management System’s processes; and managed several European and Domestic Book fairs.

Tyco International, Healthcare division - Nellcor Oximetry Systems 1999 - 2001

Senior QA Product/Quality Assurance Engineer [Corporate Layoffs]

Managed all QA aspects of new product development, design control and manufacturing; Oximeter

monitoring systems and sensors.

Wrote and performed product assurance testing; Performed Quality and finished-goods audits; Headed Customer complaints, Field Failure Analysis, corrective action and their implementation; Created QA monthly reports for the management review; Performed FMEA; Risk and Hazard Analysis, reviews, and reports; Was in charge of writing test and departmental procedures.

Updated and implemented all relevant/applicable ISO 13485, GMP and QSR standards, for quality management systems, new product development tests and procedures, and DHF files.

LifeScan Inc. (J&J) [Blood Glucose Monitoring Systems 1988- 1999

Senior QA Product/Quality Assurance Engineer (R&D and QA)

In charge of all aspects of new product development quality assurance activities, design control, field failure analysis and reporting.

Managed new product qualifications, design controls, and system verification tests; Responsible for preliminary screening and evaluation of customer complaints; Created corrective action plans and made corrective action recommendations; Supervised corrective action implementation and its follow-up verification activities.

Managed design projects, engineers and technicians, and interfaced with all related departments; Conducted formal management reviews, and reporting.

In charge of writing and reviewing QA related protocols and procedures, using the US, Canadian, European and other related standards.

In charge of field failure analysis section of assigned products and reporting.


ISO 13485 – 2016 Training Certificate 12-29-2017, World Medical Device Organization (WMDO)

Masters of Art, Organizational Management (MAOM), University of Phoenix, San Jose, CA

CAPA Initiator, Evaluator, and Investigator Certificates, Abbott Quality College

Bachelor of Science in Electronic/Electrical Engineering (BSEE), California State University Fresno

Associates Degree in Science - Engineering (ASE), Fresno City College

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