Quality/Regulatory Analyst Resume

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:

Auditing, FDA, FAA, QSM, 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.

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:

Confidential

Quality/Regulatory Analyst

Responsibilities:

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.

Confidential

Seal Dynamics / Quality Engineer

Responsibilities:

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).

Confidential

Manager Quality & Regulatory

Responsibilities:

Maintain QMS in compliance with ISO 13485, ISO 9001, MDD CE, CMDCAS and FDA CFR 21/QSR 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 documentation and inspection personnel.

Quality Assurance Consulting / Consultant

Confidential

Responsibilities:

Consult with Aerospace and Medical Device companies, other consultants, and individuals with 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 and QSR 820.
Perform inspection of client’s product and train their QA staff in inspection techniques, calibration logistics, supplier evaluation, drawing interpretation issues and other QA technical support.
Perform internal audits of clients Quality system(s) and provide recommendations.

Confidential

Orthopedic Designs / Director of Quality

Responsibilities:

My main focus in the Director of Quality role for both organizations was the maintenance of the Quality Management System in compliance with the Code of Federal Regulations (CFR 21), QSR and cGMPs.
Perform inspection of manufactured devices. Maintain close relationship with suppliers.
Perform 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.

Confidential

Quality Auditor, Source Inspector

Responsibilities:

Perform Quality Audits on suppliers to Confidential 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 Confidential facility.
Assist suppliers with process improvement activities.

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