**** **** **

Rowlett TX ***** 847-***-****

ac4kw7@r.postjobfree.com

Syed H. Zainol Abidin

PROFESSIONAL SUMMARY

ASQ Certified Quality Engineer with extensive experience in the regulated manufacturing environment (ISO 9001/13485/21 CFR Part 820, and AS9100). Experience include supplier management, CAPAs, training, and equipment validation.

EXPERIENCE

Rockwell Collins (Aerospace and defense contract manufacturing)

Sr Quality Engineer/Certified Quality Instructor Oct 2014-Present

Provide Rockwell Collins workmanship and process training to all plant operators and inspectors (SMD/PTH component soldering, cabling, crimping, mechanical hardware stackup)

Manage the Material Review Board through timely non conformance investigations and dispositions for supplier product

Serve as the quality point of contact for high volume Wire Center of Excellence that serves all enterprise plants with wire kits for product assemblies

Provide rotational quality engineering support to operation programs

Prepares weekly/monthly quality key performance indicators to upper management

ITW Medical (Manufacturer of medical check valves for healthcare companies)

Quality Engineer July 2013-Sept 2014 (relocation)

Management Representative overseeing all aspects of the plant's Quality Management Systems

Manages and audits all critical suppliers to the plant

Create procedures and test methods to ensure product meet specifications and specific customer requirements

Track and manage all CAPAs to ensure customer and internal complaints are closed in a timely manner

Uses statistical process control techniques to analyze production trends and identify improvement opportunities

Trains employees on all quality related topics

Assists Plant Engineer with equipment validation and reporting

Prepares weekly Quality summary reports and monthly Cost of Quality to identify areas of improvement

Rexam Healthcare (Contract Manufacturing for pharmaceutical packaging and medical device companies)

Project Quality Engineer Jan 2013-June 2013 (contract)

Responsible for providing Quality support for new customer projects related to molding and automation assembly validations

Prepares Validation Master Plan and its associated protocols and Quality documents to execute each phase of the validation (DQ, IQ, OQ, PQ)

Reviews customer project requirements and specifications and convert it to Rexam s internal specifications and work instructions

Performs ISO supplier audits as part of the validation requirements

Collaborates with the manufacturing team on value stream mapping (Poke Yoke, FMEA) in project hand-off to production

Regular interaction with the customers, Program Managers, and the Manufacturing teams

FMI Inc (Contract Manufacturing for Class II and III medical silicone components)

Quality Supervisor Aug 2010-Oct 2012 (contract)

Maintain the Quality Management System

Documentation and Training

Create new work instructions and update existing procedures to address any gaps in the manufacturing process

Review customer blueprints and prepare process sheets to meet customer requirements.

Assist the dimensional team in creating CMM measuring programs and work instructions.

Process internal and external document change as required

Provide training for employees on quality related activities

Non-conformances

Handle all customer complaints and internal non-conformances from initiation to closure.

Perform root cause investigation and prepare CAR/SCAR report for customer as required.

Calibration

Log calibration records and maintain the calibration log

Perform all in-house calibration and schedule calibration work orders for all equipment.

Audit

Participate in ISO, Supplier, and Customer audits

Perform internal audits per ISO 9001:2008 and ISO 13485 as required

Prepare quality documents as related to PPAP (FAI, Control Plan, PFMEA,GRR, Flow Charts, capability studies, tool trend reviews etc.)

Participate in 6 sigma project as related to continuous improvement as required.

Baxter Healthcare Corporation (Class III medical device Manufacturing)

Quality Associate I (2nd shift) Mar 2009-July 2010 Round Lake, IL

Reviewed and dispositioned manufacturing batch records

Prepared exception reports integrating root cause analysis and corrective and preventive actions

Performed various physical tests on product

Participated in internal audits and facility inspections by FDA

Utilized Statistical Process Control techniques for trend reviews

Periodic training on GMP and GDP principles

Exposure to 5S and Lean Manufacturing environment

Sr. Quality Inspector Oct 2007-Mar 2009 Buffalo Grove, IL

Performed quality inspections related to servicing of medical devices on the field and on-site

Reviewed documentation for compliance and data integrity

Performed trend review activities for Quality Engineer

Periodic training on GMP and GDP principles

Exposure to 5S and Lean Manufacturing environment

Illinois Institute of Technology Research Institute (Contract research for toxicology projects)

Biologist I Aug 2005-Oct 2007 Chicago, IL

Executed standard laboratory techniques for data collection in the Inhalation Toxicology division for various studies involving live animal subjects.

Performed routine maintenance and calibration of inhalation devices

Periodic training on GDP and GLP principles

EDUCATION

University of Virginia 2001-2005 Charlottesville, VA

B.S. Biomedical Engineering

Certifications

ASQ CQE 12/16 99493

Six Sigma Green Belt Certified by QAI 2/2011

Training Certificate for Nikon iNexiv VMA Vision System by Nikon Metrology 8/11

Internal Auditor Certification for ISO 9001:2008 9/11

Training Certification for ISO 13485:2003 6/12

RELEVANT SKILLS SUMMARY

Extensive experience in GMP and Lean Manufacturing

Database experience (SAP, Siebel eMedical, AS400/BPCS, Trackwise)

Understanding of Geometric, Dimension, and Tolerance (GD&T)

Office Applications for technical reports and Minitab for SPC

Lead based Soldering (JBC/Metcal)

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