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Seasoned Quality/Compliance Professional seeking Houston area position

Seeking Houston area Position:Highlights of my expertise, that may be of interest to you include: § Ability to work independently and take the initiative in a team in order to meet larger team…Continue

Started May 24, 2010

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Tell Us About You/Your Company or What Type of Work You Do if Seeking Employment: I am the Quality Systems Manager for a medical Device Company. I am seeking to diversify into general manufacturing, Energy and Petroleum industries in the greater Houston area.

Post Your Resume (Remove Your Home Address, Phone and all Personal Information ie. SSN, DOB, DL#****Failure to Comply will result in your account being banned! This is not a site for commercial advertising. If you are not looking for employment you need to be a Sponsor. Click on the Advertising Tab for more information!) Protect Your Privacy and DO NOT POST YOUR PHONE NUMBER OR HOME ADDRESS. YOUR RESUME WILL POST TO THE INTERNET - DO NOT PUT ANYTHING ON YOUR RESUME THAT YOU DO NOT WANT OTHERS TO SEE!: PROFILE
Established professional with over 21 years of Quality Assurance/Compliance expertise. Results driven leader with broad experience in organizational development, training, and compliance. Capable of a wide range of leadership roles.
AREAS OF EXPERTISE
§ Ability to work independently and take the initiative in a team in order to meet larger team goals
§ Articulate, diplomatic, persuasive; easily establishes rapport and credibility with people at all levels
§ Streamlines field methods and strategic procedures effecting time and resources
§ Proficient in MS Office, Visio, Publisher, Project
§ Bilingual in English/ Limited Spanish
KEY AREAS INCLUDE
Accomplished Industries Electronic Mfg, Commercial Mfg., Machine Shop, DoD Weapon Systems. Foreign Soil Mfg. - China/Mexico, Investment Casting, Medical Device, Pharmaceuticals, Biotechnology, Computer Mfg., Aerospace, Start-ups to Fortune 500’s
Manufacturing Precision Machining/EDM, Plastic Injection/Molding, Electronic Mfg./Assy., Automated/Manual Assy., Sterilization, Non-Destructive Testing, Validations – IQ/OQ/PQ, Import/Export documentation
Accomplished Skill Sets Risk Management, Hazard Analysis, HAACP, FMEA, Design Control, Project Management, Internal/External Auditing, Lean Manufacturing, Quality Engineering, Supplier Management, Microsoft Word, Excel, Access, Visio, PowerPoint, Publisher, Project
CERTIFICATIONS
QABQSA Certified Lead Auditor - ISO 9000/13485 HACCP trained, ISO 14971 Risk Management
ACCOMPLISHMENTS
v Winner, "Most Improved Quality" company award, 2007
EXPERIENCE
July 2009 – Current Quality Systems Manager, NovoSci, Conroe, TX
I am the company management representative and owner of the Quality Management System, for a class II medical device manufacturer according to FDA 21 CFR 820, ISO 13485, ISO 14971, and ISO 11135.
May 2005 – Oct 2008 Senior Compliance Analyst, Fresenius Medical Care, Reynosa, Mexico
Lead auditor and manager of the Compliance Program.
· Trained and certified all auditors; provided auditing; conducted internal audits
· Reviewed and approved Protocols and Validations and Quality Plans for integrity and compliance to current GMP/ISO compliance
· Hosted external audits; FDA and TUV, and external audits from customers
· Resolved compliance issues
· Departments include Microbiology, assembly, warehouse, molding, and extrusion