Resume - ISO Implementation, Documents, Records, Archival Management, QA Manager, Writin...

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Resume #79664

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MANUFACTURING/QUALITY ASSURANCE MANAGEMENT

Summary

Well-rounded take charge and energetic individual with 20 years of quality experience seeking new challenge and opportunities to apply consummate skills in manufacturing. I can fit into many quality positions because of my diversity in quality applications. Ability to anticipate customer needs be proactive. Understanding business problems, providing recommendations for business process improvements, and providing technology solutions that support business objectives is what I offer.

Specialized Skills

Project Management, ISO & Regulatory Compliance, QA/QC Implementation,
Quality Engineer, Quality Improvement, Supplier Quality,
Auditor/Investigator, R&D Design Control, Imaging and Archival,
CAPA Investigation, Process improvement, Technical Writing,
Document and Data Management, Record Retention,

Employment History

Supervisor Document & Data Management / Technical Writer 2005–2008
Baxter Healthcare
Pinellas Park, FL

Manage within an intensely fast-paced high growth organization that has doubled revenues consistently year over year for the past 4 years. Supervised a staff of four- instilled a sense of urgency regarding project deadlines and quality issues.
Correlated design activities with engineers and managers to produce documentation for
R & D departments with time-sensitive projects. Participate in Design Review, Validation and CCB tasks. Provide CAPA/FDA expertise and guidance to R & D in investigating root causes and taking corrective action. Perform proofreading tasks as required. Act as focal point for third party audits.
Created and implemented new workflow management system for documents and data, information management, imaging and archival within 6 months.
Eagerly accepted responsibility for Calibration, ESD and EHS activities within
Engineering test lab with 20 Technicians.
Provided archive training and reduced backlog by 30%.
40% reduction in paper documentation by utilizing electronic media.
Took charge during FDA audits of retrieving documents for review.
Gained budget control on purchasing of Calibration equipment by mandating all equipment requests is approved by me prior to release to Purchasing.
Authored test, position papers, procedures and manuals crucial to R&D processes.
Coached and monitored engineers responses to corrective actions in order to meet established due dates for closure.

Process Improvement/ CAPA/ Technical Writer 2003–2004
Kinetic Concepts
San Antonio, TX

Selected by global medical device company lead, support and implement improvements to processes through creation of value added documentation, verification and validation to ensure compliance with ISO-13485 and FDA requirements prior to third-party activities. Research, develop and reduce cost of wasted material and reduce safety violations.
Performed GAP analysis on product lines to determine KanBan feasibility and identify process weakness.
Collaborated with engineering assisted CAPA closure. Ensured identification of root causes.

Reduced scrap of shelf-life materials by establishing expiration deadlines and stricter controls on materials.
Initiated MSDS program that reduced waste by 15% in first six months.
Authored 52 documents to comply Sarbanes-Oxley, ISO, and FDA audits within 5 months.
Wrote validation test documents for prototype units under test.

Quality System Manager 2001–2002
Takata Seatbelts
San Antonio, TX

Challenged to ensure Automotive Company with four major manufacturing plants offshore met the requirements of ISO 16949 and QS 9000 that would allow retention of Certification. Managed, scheduled and led audit program for Division, performed internal and external audits including suppliers.
Orchestrated a centralized documentation system, improved interpretation between Mexico and US sites by 40%. Revised or disposed of repetitious documents. Saved $75,000 in 18 months.
Employed easy to understand language towards text revisions that effectively addressed diverse audiences. Achieved maximum results and reduced unnecessary ECN, ECO generation.
Strengthened and reinforced corporate requirements with offshore facilities. Emphasized team approach and collaborated effort to solve problem areas.
Tweaked quality system documents that led to retention of Certificate.
Saved $55,000 first year by verifying changes were necessary and approved prior to implementation at offshore location.
Wrote SQM and coached suppliers on meeting SQM requirements. Consulted on ISO
processes.
Reduced costs of materials by $71,000 in eight months on joint venture with volume suppliers.

Quality Engineer/ISO Consultant 1999–2001

Southwest Research Institute
San Antonio, TX

Afforded an opportunity by a Research and Development company specializing in Destructive and Environmental testing nuclear components to move company forward toward ISO Certification.
Took charge of document control, restored and structured quality system that fit easily into ISO initiative.
Interface with engineering to ensure content accuracy in all published hard copy and electronic media.
Managed document control and staff. Wrote documents in conjunction with senior engineers.
Developed and tailored technical documents to fit clients' needs that saved $60,000.
Performed training from top-down on quality systems, and cut training costs by
$50,000.
Installed electronic document management system that facilitated quick responses to drawing and document requests and saved $30,000+ in first year.

Quality Systems Manager 1992 – 1999

Data Race
San Antonio, TX

Challenged to revitalize and prepare quality system to come up to par to obtain ISO 9001 Registration and Certification within 24 months. Wrote all QMS documents to meet ISO requirements. Registered company 6 months ahead of schedule.

Education

B,. S, Business Administration--------Sindh University– Karachi West Pakistan
Diploma in Electronic Technology----Edison Technical Institute CA
Train the Trainer---------------------------University of Florida
Certified Lead Auditor -------------------SGS Certification Services Houston TX
CQA--------------------------------------------ASQ
Ongoing studies for CQM----------------ASQ

Affiliations
Hold Membership in ASQ, STC, and ARMA

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