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Medical Device Quality

Location:
Safety Harbor, Florida, 34695, United States
Posted:
August 27, 2018

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Resume:

Jon London

**** **** ******* **.

Safety Harbor, FL 34695

727-***-****

ac6tzj@r.postjobfree.com

PROFILE:

Professional Quality Assurance Manager, Analyst, Auditor, Engineer, Technician and Inspector, with over twenty years of Quality logistics technical support in various regulated industrial applications.

SUMMARY OF QUALIFICATIONS:

Auditing, FDA, FAA, QMS, QSR, ISO, AS, Regulatory Affairs, Complaint Investigation, CAPA, Documentation, Statistical Process Control, Equipment Calibration, Inspection, G, D & T, Supplier Surveillance (SQE), Lean Manufacturing, FMEA, Risk Analysis, V & V, Management Representative, DMIR.

INDUSTRY TYPE EXPERIENCE:

Medical Device, FDA, Aerospace, FAA, Mechanical, Machining, Metal Working, Raw Material, Welding, Assembly, Production, Electro-Mechanical, PCB, Soldering, Coating, Plating, Molding, Polymers, fabrics, Stamping, Tooling, Clean Room, Special Processing.

PROFESSIONAL EXPERIENCE:

2017-Present - L3 Security Detection Systems / Quality Engineer

Provide Quality Engineering support to manufacturing floor involving nonconforming materials. React in an MRB capacity for the disposition of NC’s. Communicate with suppliers for corrective action on nonconforming purchased materials. Maintain internal audit program and facilitate ISO 9001 compliance. Assist Quality Manager with special projects and fill in for QM when absent.

2016-2017 - SCC / Quality/Regulatory Analyst

Interpret FDA regulations to BU personnel. Review and approval of new or revised documentation for regulatory compliance. Coordinate internal and supplier audit program. Conduct training on QMS and FDA regulations for new hire personnel. Perform regulatory assessment for medical device classification. Conduct MedWatch reviews. Present QMS data for executive management review. Participate in CAPA process including root cause assessment, corrective action and effectiveness of correction action taken. Perform other tasks in support of the quality management system.

2013-2016 – Heico Aerospace - Seal Dynamics / Quality Engineer

Provide maintenance support to QMS by performing supplier evaluation, supplier quality/process audits, report supplier performance. Manage internal audit program, and CAPA/SCAPA request activities. Manage nonconforming material, MRB activities, measuring, inspection and test equipment calibration. Represent Quality in engineering design reviews and supplier “kick-off” meetings. Assemble QMS data for management review and other activities as directed by the Quality Assurance Director. FAA ODA Unit Member Designee (DMIR).

2010-2013 - Rhein Medical, Inc. / Manager Quality & Regulatory

Maintain QMS in compliance with ISO 13485, ISO 9001, MDD CE, CMDCAS and FDA CFR 21 Part 820. Provide management direction for global medical device manufacturing company. Maintain all documentation including QMS, SOP's, WI's, CFG, licenses and certifications. Chair notified body, customer, 3rd party audits, management reviews, CAPA activities, complaints, nonconforming material review board, product launch activities, product inspection, device classification and listing. Supervise quality staff including document control and inspection personnel.

2007-2010 - Quality Assurance Consulting / Consultant

Consult with Aerospace and Medical Device companies, other consultants, and individuals regarding Quality Assurance compliance issues. Assist Aerospace companies with AS9100, ISO 9001 and FAA requirements. Assist Medical Device companies with ISO 13485, FDA, MDD and cGMP standards compliance including CFR 21 part 820. Perform inspection of client’s product and train their QA staff in inspection techniques, calibration logistics, supplier evaluation, drawing interpretation issues and other QMS technical support. Perform internal audits of clients Quality system(s) and provide recommendations.

2003-2007 - Promedica, Inc. /Orthopedic Designs / Director of Quality

My main focus in the Director of Quality role was the maintenance of the Quality Management System in compliance with the Code of Federal Regulations (CFR 21 part 820), cGMPs. Supervise inspection of manufactured devices. Maintain supplier compliance. Perform internal auditing function in compliance with ISO 13485. Maintain all product device history records. Perform all compliance activities including CAPA, NCR's, complaints, equipment calibration, FDA and customer audits.

1999-2003 - Honeywell Technical Services / Quality Auditor, Source Inspector

Perform Quality Audits on suppliers to Honeywell facilities. Audits are conducted within the parameters of the ISO, AS, or QS 9000 Quality Standard. Also perform source inspection of product being supplied to a Honeywell facility. Assist suppliers with process improvement activities.

1996-1999 - Aerospace Specification Metals / Corporate Quality Manager

Managed Quality Assurance system for a multi-site raw material distributor. Achieved ISO 9002 and AS 9000 certification for all facilities (Fort Lauderdale, FL, Hartford, CT and the United Kingdom). Performed compliance to all elements of the standards including contract review, approval of suppliers, inspection equipment calibration, document control, corrective / preventive action and audits. Maintained compliance and approval status to the aircraft and aircraft engine manufacturers.

EDUCATION:

St. Petersburg College:

AS Engineering Technology Biomedical Quality Systems (Cum Laude)

Lean Manufacturing / Six Sigma Green Belt (Certified)

Quality Systems for Medical Device Manufacturing (Certified)

Geometric Dimensioning & Tolerancing

ACCREDITATIONS:

Certified Quality Auditor - ASQ/CQA

Senior Member of American Society for Quality



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