9/2008 - 12/2008

Regulatory Compliance Associates Inc

Contractor / Freelance

• Assignment Arrow International –Teleflex Medical, Reading PA Provide Quality Engineering support of the re-mitigation team working to clear FDA audit findings, written early 2008. The primary responsibility is rewriting procedures and instructions, as well as having drawing up-dated to clearly define process, manufacturing and inspections. Work with R&D, Manufacturing engineering, Document/Change Control and Training Specialist ensuring the execution of changes/corrections necessary. The project required clearing corrective actions written by the FDA (not compliant with 820 parts 210 & 211 as well as 21 CFR part 11) of method used for product transfer from R&D to Manufacturing, methods used in manufacturing and the production history records/files produced

10/2007 - 7/2008

Regulatory Compliance Associates Inc

Contractor / Freelance

• Assignment GE Healthcare Waukesha WI Performed validation reviews on software and hardware requirement procedures, worked with engineering providing corrective action recommendations and approving documentation for use in test and inspection. Trained engineering in (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) generation. Reviewed the results of the validation testing performed for accuracy and completeness. The project required compliance with ISO13485, cGMP, FDA, CE, ISO14971 Risk Management requirements. Wrote protocols and reports for the validation of equipment used by manufacturing and quality assurance. Executed and coordinated execution of installation qualification IQ, OQ and PQ of equipment and product. Worked on site at GE Healthcare Engineering in Waukesha, WI in 2007, January 2008 continued working from my home-office, in Milpitas Ca via the internet.

5/2005 - 9/2007

Genmark Automation

Individual Contributor

• Created an ISO9000:2000 compliant system; performed an gap-assessment of the companies status – presented the presentation to management obtaining approval and budget for development and implementation; working with engineering, manufacturing, document/change control and support personnel, rewrote/wrote QA Manual, SOPs, Inspection Instruction, etc. Performed operational and compliance audits company-wide to ensure the systems were in-place actually and functional (effective/efficient) as well as compliant with ISO9001:2000. Arranged ISO audit with DNV (QMS Certification Company) and achieved certification in 2006 (within one year of initiating the project), recertification in 2007, 2008. Work with engineers and manufacturing (Assembly & Machine Shop) supporting the development and build of robots (new and sustaining catalog product) ensuring Internal Audits are performed and effective correction. Performed all quality related activities such as; project design phase reviews, validation analysis/test, risk analysis, product transfer, FMEA’s, root cause analysis corrective/ preventative action, document control (ECR/ECOs), implemented SPC program; data collection (statistical reporting), incoming inspection, 1st article inspection, in-process and final inspections/test, and calibration in-house/ external. Trained/Certified employees all levels of company (internal audit, quality/manufacturing/engineering methods. Ensure regulatory compliance in production processes (CE, S2/S8 safety/hazards) Performed as supplier quality engineer duties coordinating MRB, qualifying suppliers, first article, supplier CAPA program, worked with suppliers to develop method to meet our needs and adapting material to RoHs/WEEE. Performed as customer quality engineer (root cause analysis, diagnose and correct improper quality practices, and reporting solutions. Supported continues improvement of quality management system. Prepare management reports.

7/2004 - 4/2005

VSC (contract @ Lockheed Martin)

Contractor / Freelance

• As the project engineer serve as the liaison between Lockheed Martin and supplier of missile modules. This included being the design engineering team’s quality representative for; product evaluation, validation, root cause analysis, development of FMEA’s, corrective action resolution, change board, design reviews and reporting (status, statistical performance reporting) to the customer (Army Department). Responsibilities included ensuring quality and manufacturing compliance of subcontractor’s product, at their site and internal first article. Performed as QA witness and approved verification of the modules at Lockheed Martin. Obtained certification as a LMC Certificated Quality Engineer.

7/2003 - 7/2004

Highland Metals

Contractor / Freelance

• Converted an existing ISO9002 system to meet ISO13485:2003. Re-wrote the QMS, ensured compliance (restructuring where necessary) of systems including medical design history files (test and inspection), completing risk analysis/assessments to ensuring CE mark, FDA 21 CFR Part 820 compliant design and manufacturing transfer program. Performed internal auditor training and companywide ISO training; coordinated company-wide project to up-date documentation, converting from a paper to electronic document system. Achieved ISO13488 registration (CAMCAS via BSI) Nov. 2003.

6/2002 - 10/2002

Masterworks Electronics

Contractor / Freelance

• (PCB, Cabling, Test/Repair)¬: Established, Wrote and Implemented critical systems: New Product Introduction, SPC, ECO, MRB, CAPA, External Calibration, Inspection, Circuit Testing and ESD. Overseen QA/QC functions (IPC610 & 620).

10/2001 - 6/2002

Infinity Technical Solutions

Contractor / Freelance

• (Semiconductor/Eng Services) ¬–: Established an ISO 9000:2000 quality system, wrote all documents (manual - forms). This was a start-up company requiring all processes developed including; doc/change ctrl, audit, supplier selection/qualification, business planning and improvement. Specified/set-up technical operations; Receiving Inspection 1st article/sampling, Process Ctrl, SPC, CAPA, GR&R, FMEA’s, Calibration, RMA program, etc. Designed/Programmed a supporting database: line data collected, tracked, scheduled & evaluation reports.

8/2000 - 9/2001

Argosy Industries

Manager

• Managed 50 people: Manufacturing Supervisor, Quality Supervisor and support personnel; inspectors, customer service, production, and warehouse. Wrote and gave performance reviews. Performed site planning with the President. Developed and presented management reports; budget, product performance (on-time-delivery), inventory, customer satisfaction, personnel and quality. Coordinated the up-grade of the ISO9002 system to ISO9000:2000 (included converting from paper to electronic). Created work instruction database and organized quality, production, test activities (monitoring/control via SPC reporting) and projects. Integrated QS9000 elements (PPAP, PFMEA, Gage R&R) to ISO9000 Quality System. (Customer Mitsubishi). Provided engineering support for Tape & Reel, Customer Projects and Test functions.

6/1999 - 8/2000

MRC,

Manager

• Rewrote ISO9002 documentation system (maintained certification), converted from paper to electronic. Audited/Sustained ISO system. Designed/Programmed an MRP style database (front end - Access): production quality data, tracked, scheduling, as well as providing work instructions & evaluation reports (SPC, Trend & Pareto). Created, administered inspection system, corrective/preventative action system.