Manager, Quality/Project Engineer

Allen D Tabor

RAC (US); CQE, CBA, CSSBB; CPMA; CBET

**** * ****** ** ****, Austin, TX 78727 C: 724-***-**** E: ********@*****.***

SUMMARY

I am a practical customer and results oriented Quality Systems (QS) leader with 10 years experience with Class II & III medical devices in leadership, individual contributor and consulting/contract roles. My experience is summarized as follows:

Positions I have held included quality systems and post-market surveillance & vigilance management, quality engineering and pre-market regulatory affairs

In leadership roles I have managed 6 - 22 direct report complaint investigators, clinical vigilance specialists (RN & CRT), investigation engineers/technicians, and correction and removal specialists

Processes and roles I have managed, led or performed supported Class II & III capital equipment and orthopedic implant new product development and sustaining engineering

My expertise includes post market risk analysis and assessment (ISO14971); CAPA, RCA, gap analysis, personnel management, business reporting/management review and QS remediation

My effectiveness as a manager and leader has been enhanced by my commitment to personal continuing education and the professional development of direct report individuals and teams

My cross-functional successes have been through partnering, supporting, advising and training suppliers and customers (internal and external) of quality systems processes

Business leaders & processes I have engaged as a result of process analysis have included customer service, service, technical product support, risk management, NPD, RA & marketing

The teams I have managed delivered performance that met and exceeded organizational process key performance indicator (KPI) goals while concurrently improving the audit readiness to Agency and Notified Body Standards, demonstrated by the receipt of zero major or minor observations for the processes I managed identified during 2 Notified Body and 1 Agency audit

PROFESSIONAL EXPERIENCE (DEVICES-MANUFACTURING INDUSTRY)

QUALITY SYSTEM CONSULTANT, CINCINNATI, OH 02/11-03/11

COMPLAINT/MDR PROCESS REMEDIATION SME – CLASS II DEVICES

Post Market Surveillance process corrective & preventive actions and consultation to support fulfillment of FDA 483 observation remediation commitments and timelines

Remediated 100% of FDA & 3rd Party complaint & MDR observations and commitments

Completed revision/release & training of Complaint/MDR SOPS & complaint database system

QUALITY SYSTEM CONSULTANT, ANN ARBOR, MI 12/10-01/11

COMPLAINT/MDR PROCESS REMEDIATION SME – CLASS II/III DEVICES

Post Market Surveillance process consultation to support the fulfillment of FDA 483 observation and Consent Decree remediation commitments and timelines

Identify and communicate complaint, MDR and product investigation lab process/SOPS deficiencies

Characterize & map complaint database fields to MDR decision/submission SOPS/WI

ZIMMER SPINE, AUSTIN, TX 05/10-12/10

MANAGER, QUALITY SYSTEMS – CLASS II/III DEVICES

Managed 6 member global post market surveillance team responsible for complaint handling, adverse event reporting, product investigations, and corrections and removal processes

Developed and implemented MDR reporting strategy & training in response to Agency observations

Integrate site level post market quality system SOPs into a harmonized divisional SOP and practice

PHILIPS RESPIRONICS, HOME HEALTHCARE SOLUTIONS, MONROEVILLE, PA 08/07-04/10

MANAGER, POST MARKET SURVEILLANCE – CLASS II/III DEVICES

Manage a 22 member high-volume global complaint handling process, product investigation laboratory and post market vigilance (PMV) team for a $1.5 billion Class II & III device business (5 business units)

Remediated MDR/MDV backlog through characterization of “similar” recurring similar issue criteria

Implemented process and product quality KPI monitoring & reporting in all business reporting

GE HEALTHCARE– CLASS II DEVICES

QUALITY & REGULATORY ENGINEER, INVASIVE CARDIOLOGY, WAUWATOSA, WI 09/05-08/07

Support new and installed base / pre and post market product development, clearance and sustaining engineering and regulatory affairs requirements for Class II Invasive Cardiology business unit

CAPA approval, complaint processing, MDR/PMV reporting decisions, PM risk assessment

Delivered new/sustaining Quality Engineering & Regulatory Affairs (510(K) K061741)

COMPLAINT LEADER, CLINICAL SYSTEMS, WIRELESS SYSTEMS, MILWAUKEE, WI 10/01-09/05

Led cross-functional complaint handling unit in complaint reviews/processing, risk assessment, MDR decisions and CAPA needs assessments for Wireless and Clinical Information Systems business units

Lead completion/completed over 400 post market risk analysis and assessments

Implemented a comprehensive pre-investigation MDR reporting decision protocol

PROFESSIONAL EXPERIENCE (DEVICES – HEALTHCARE / CLINICAL SETTING)

KADLEC REGIONAL MEDICAL CENTER, CLINICAL ENGINEERING (CE), RICHLAND, WA 04/89-10/01

SENIOR CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN

Provided biomedical support in the clinical setting; developed biomedical equipment inspection SOPs

INTERMOUNTAIN HEALTHCARE, TECHNICAL SERVICES DIVISION, OGDEN, UT 10/86-04/89

CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN

Provided clinical laboratory and respiratory therapy technical & clinical support in a 3-state region

KEY EXPERIENCE & COMPETENCIES

Complaint & MDR Process Management Change and Continuous Improvement Leadership

SOP/WI Development /Revision/Training Mentoring / Team Building / Staff Development

CFR 820/803/806 & ISO 13485 Remediation Performance Reviews / Talent Acquisition

Complaint & MDR/MDV Process Monitoring SIPOC / Gap Analysis / RCA / CAPA / Corrections

EDUCATION

M.B.A. (WITH DISTINCTION) KELLER GRADUATE SCHOOL OF MANAGEMENT (KGSM), MILWAUKEE, WI

GRADUATE CERTIFICATE, PROJECT MANAGEMENT, KGSM, MILWAUKEE, WI

GRADUATE CERTIFICATE, BUSINESS ADMINISTRATION, KGSM, MILWAUKEE, WI

B.SC. ELECTRICAL ENGINEERING, WASHINGTON STATE UNIVERSITY, PULLMAN, WA

A.A.SC. BIOMEDICAL ENGINEERING, SPOKANE COMMUNITY COLLEGE, SPOKANE, WA

PROFESSIONAL CERTIFICATIONS / INDUSTRY TRAINING

REGULATORY AFFAIRS PROFESSIONALS SOCIETY - RAPS (VOTING MEMBER #9224365)

RAC, REGULATORY AFFAIRS CERTIFICATION (US)

PROJECT MANAGEMENT INSTITUTE - PMI

CPMA, CERTIFIED PROJECT MANAGEMENT ASSOCIATE

AMERICAN SOCIETY FOR QUALITY - ASQ (SENIOR MEMBER #63442837)

CQE, CERTIFIED QUALITY ENGINEER (#51755)

CBA, CERTIFIED BIOMEDICAL AUDITOR (#472)

CSSBB, CERTIFIED SIX SIGMA BLACK BELT (#8307)

CSSGB, CERTIFIED SIX SIGMA GREEN BELT (#2349)

CQIA, CERTIFIED QUALITY IMPROVEMENT ASSOCIATE (#2437)

INDUSTRY TRAINING AND *SPEAKING ENGAGEMENTS

*FDANEWS, 7TH ANNUAL MEDICAL DEVICE CONGRESS, MDR REPORTING, BALTIMORE, MD ‘10

ADVAMED, INTEGRATING COMPLAINTS WITH CAPA & MANAGEMENT REVIEW, ORLANDO, FL ‘08

AAMI, QUALITY SYSTEM REQUIREMENTS AND INDUSTRY PRACTICE, DENVER, CO ‘08

ASQ, INTEGRATING RISK MANAGEMENT INTO THE QUALITY SYSTEM, BALTIMORE, MD ‘07

ADVAMED, 510(K) SUBMISSIONS “101”, FREEMONT, CA ‘06

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