Quality Engineer Contract Consultant Resume Charlottesville, VA - Hire IT People

SUMMARY:

Highly skilled & experienced Medical Device Quality Engineer in all aspects of Quality functions, supporting design engineering/design control development, implementation, and remediation of Class II and Class III devices in compliance with FDA & international (ISO 13485) device regulations.
Skilled in QSR (820), EU (ISO 13485), and ISO 9001/AS9100 requirements, Design Controls, SOP/Work Instruction development, Design History File maintenance, gap analysis and remediation, specifications, protocols, Verification & Validation testing, Supplier Quality/Vendor Assessment, CAPA process, investigations & remediation, GMP, Safety & Effectiveness testing, internal auditing and mitigation, Risk Management/ FMEA (ISO 14971), complaints/failure analysis, product improvement.
Risk Management (e.g. FMEA, FTA, HA)
Corrective and Preventive Actions (CAPA)
SOP, protocols & reports, change management
Complaint investigations & root cause analysis
Creating and maintaining Design History Files
Biocompatibility & Human Factors testing
Verification/Validation testing, Supplier Quality
Internal auditing and remediation
Compliance with 21 CFR 820 & ISO 13485
Managing tasks & projects to meet timelines

PROFESSIONAL EXPERIENCE:

Confidential, Charlottesville, VA

Quality Engineer Contract Consultant

Responsibilities:

Medical device Design History Files (DHF) Remediation/Risk Mgt and New Product Development

Confidential, Elkridge, MD

Mission Assurance Quality Engineer

Responsibilities:

21CFR820 Design Controls, Design History Files, Supplier Quality, Internal Auditor, documention
Supplier Quality Engineering: remediation of supplier process validation, supplier quality CAPAs and audit findings, authored overall Supplier Quality Management SOP, Supplier Process Validation SOP, revised Work Instructions, and forms, created, maintained, and held to Supplier Quality Remediation Project Timeline

Confidential, Bethesda, MD

Quality Engineer

Responsibilities:

Product development, SOPs, Verification &Validation, complaints, Corrective and Preventative Action (CAPA), Audit Finding Reports, audit remediation, FDA inspection
Complaints/root cause analysis, design reviews, Risk Management (authored FMEA procedure), Design History File development, remediation & internal audit, FDA submission preparation, mentored staff.
Mitigated and closed open items from QSR and ISO 13485 audits.

Confidential, Silver Spring, MD

Biomedical Engineer/Medical Device Lead Reviewer

Responsibilities:

Completed Medical Device Reviewer Program (RCP) curriculum & passed RCP exam.
Authored and provided reviews of 510(k) premarket submissions (Traditional, Special, Abbreviated).

Confidential, Rockville, MD

Senior Device Engineer

Responsibilities:

Authored/revised QSR documentation (e.g. CAPA SOP, Work Instructions, and forms) for the successful merger of Meretek, a medical device company, into Confidential .
Led Technical Operations’ support of BreathTek Infrared Spectrophotometers, in vitro diagnostic radiological devices and accessories.
Performed/documented complaint investigations and on - site root cause analysis of mechanical engineering investigations of device problems, using CAPA process to resolve two product recalls, quickly returning products to profitable $5 million market.
Produced product development documentation for antimicrobial drug/device combination product.

Confidential, Dermik Labs division, Berwyn, PA

Clinical Consultant

Responsibilities:

Created technical and QSR documentation for FDA submissions of New-Fill, a Class III implant device (Aventis’s first) that led to approvals for an IDE and PMA for two separate indications.
Created device verification and validation test protocols and reports, reducing development time.
Assured adherence to US 21 CFR 820 QSR and (international) ISO 13485 regulations.

Confidential, Exton, PA

Senior Product Development Engineer

Responsibilities:

Created and performed in vitro functional DOE test protocols of devices that led to clinical use.
Directed preclinical animal studies that led to FDA approved clinical studies.
Created device Instructions for Use for physicians that were validated during clinical studies.

Confidential, Somerville, NJ

Staff Specialist, Corporate Project Management

Responsibilities:

Assured adherence to Confidential ’s Global New Product Life Cycle stage gate process, reducing time to market & collaborated with project teams to develop business plans and presentations.

Confidential, Fairfield, NJ

Senior Research and Development Engineer/Project Leader

Responsibilities:

Led cross-functional team for FlexiSheath™ kink resistant catheter introducer, resulting in a 510k.
Led cross-functional team for VasoSeal™ vascular closure device, resulting in an IDE.
Led hemolysis studies for intra-aortic balloon/heart bypass cannulae, resulting in a 510k.