St. Petersburg, FL
CAREER SUMMARY: 25 years experience in the Medical, Electronics and Aerospace manufacturing industries. Strong background in Machining Processes, Sheet Metal fabrication, welding/soldering principles, Paint applications, Metal coating/plating, SPC, 6 Sigma, Auditing, ISO/AS9100 Quality Systems and Lean Manufacturing Principles. Strong knowledge of Industry Quality Systems and Standards such as: ISO/AS9100, ASME, ANSI, ASTM, MIL-STD. FDA and CGMP regulations, ISO 13485 and CFR 820 compliances, CFR 29 and OSHA 511 Occupational Health & Safety for General Industry Certified.
SKILLS: Excellent work ethics, able to task multiple projects. Strong written and verbal communication skills. Ability to interpret drawings/schematics and use various measuring equipment, including programmable CMM. Strong knowledge of Statistical Process Control (SPC). Set up and operate various machine tools such as, CNC and Manual Lathes and Mills, RAM EDM, drill press, punch press, break press and plastic extrusion. Operation of brazing, welding and soldering equipment. Electro-mechanical Assembly. Control Panel wiring and test. Strong Computer skills utilizing various software such as: InfinityQS (SPC), Clearquest, Trackwise (CAPA), MPact, AutoCad, CadCam, Solidworks, Microsoft Office and more.
EDUCATION: 1994 obtained a BA Mechanical Engineering, 2002, Associates in Quality Technologies.
EMPLOYMENT:
Polypack Inc.
Position: Quality Manager/Safety Coordinator
Pinellas Park, FL, March 2010 to Present
L3 Communications
Position: Quality Manager
Largo, FL, Jan. 2007 to March 2010
Baxter Healthcare
Position: Quality Engineer
Largo, FL, July 2000 to Jan. 2007
Circon Surgitek
Position: Quality Engineer
Racine, WI, March 1989 to June 2000
PROFFESIONAL EXPERIENCE:
Develop, implement and manage the Quality Management System. Prepare QA/QC manuals, plans, instructions and procedures. Serve as the Deputy Management Representative in preparation and achievement of company ISO/AS9100 Certification.
Plan, direct and perform QA audits of internal organizations. Perform supplier Audits to ensure material procurement and quality. Create and perform process and fixture validations (IQ, OQ, PQ). Manage company CAPA process and procedures.
Provide quality-assurance (QA) support activities on assigned project/program and/or functional area(s) to ensure that products or services provided are in accordance with customer and company requirements.
Regularly interact with representatives from a variety of functional groups, including upper management, design/engineering, purchasing, production, sales, customers and other personnel.
Coordinate, track and document Quality Improvement Team Meetings. Identify and report quality issues or trends on an assigned area or product. Create and generate reports based on data from a variety of sources including SPC, CAPA, Customer Complaints and Field Service.
Recommend and/or verify the implementation of appropriate corrective actions and/or process improvements for all quality issues.
Perform Document reviews from a quality perspective on documents prepared by internal or external organizations, such as quality manuals and procedures, technical deliverables, test plans and procedures, purchase orders, and subcontra...
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