Quality Assurance Project Manager

OBJECTIVE

To obtain a challenging position that utilizes my experience and abilities

in Quality Assurance, Regulatory Compliance, Project/Program Management,

Documentation and Configuration Management. I am looking for a progressive

environment, where I can make a difference and contribute to success.

EXPERIENCE

Integra Pain Management, West Valley City, Utah 2010 to 2013

Medical Device Manufacturer

Quality Assurance and Regulatory Manager

. Served as Management Representative

. Managed a QA department of six employees, QA Engineer, QA Specialist,

Document Control Specialist and three Inspectors.

. Responsible for coordinating, implementing and facilitating process and

procedure development in a FDA CFR 820 and ISO 13485 environment.

. Managed with purchasing the supplier management processes and

improvements.

. Managed Document Control, Incoming Inspection, In-Process Inspection and

Final Product Release

. As Management Representative prepared and held Quality System Management

Review meetings with upper management

. Established and maintained internal quality audit system and external

supplier audit programs

. Managed the Corrective and Preventive Action and Customer Complaint

systems.

. Responsible for environmental monitoring, sterilization (EO) validation,

and equipment validations.

REVA Medical, Inc., San Diego, California 2004 to 2010

Medical Device Manufacturer

Engineering Project Manager

. Created and maintained project plans and project schedules

. Managed and tracked project tasks/activities and ensure timely completion

of project activities to meet company timelines

. Managed activities and resources to resolve issues and reach effective

decisions in a timely manner

. Addressed project issues and risks affecting project goals and

deliverables and implement solutions to overcome perceived or real

obstacles to maintain timelines

. Reported project status and timelines to Senior Staff as appropriate

. Documented and communicated project meetings, developments and decisions

. Ensured the proper documentation and project activities in accordance

with company quality systems

. Maintained project Design History Files and ensure compliance with

Company design control systems

. Support risk analysis efforts in accordance with ISO 14971, providing

input and perspective regarding risk assessment.

Quality Assurance Manager

Management Representative

Senior Quality Assurance Engineer

. Initiated action to improve and maintain equipment files and associated

documentation including: installation (IQ), operational (OQ)

protocols/reports, calibration and preventive maintenance records.

. Designed and implemented the Design Control System to be ISO 13485 and

FDA QSR compliant. Trained development group in Design Control.

Participated on project teams, as QA Rep and to manage and develop the

Design History File (DHF) for each of the product development phases.

. Defined requirements for and wrote protocols, reports and managed the

validations for Packaging, Shelf-Life and Sterilization.

. Defined and managed the validation system for products, processes and

systems

. As Lead Auditor, managed, maintained and improved the company Audit

System, to ensure compliance to all current customer, regulatory and

international requirements including Quality System Regulations (QSRs)

per CFR 21 Part 820 and ISO 13485:2003. Developed audit schedules and

developed, managed and implemented training program for auditors.

Resulting in a non-conformance free TUV Surveillance Audit in 2008 and

minor MNCs in the following years.

. Refined and managed the training system for all employees

. Served as the company Quality Management Representative, initiated and

held Management Reviews to meet the ISO 13485 requirements

. Created procedures, implemented and managed the Risk Management System to

meet ISO 14971 requirements.

. Actively managed the Company's Quality Management System, including the

CAPA, Design Control and Risk Management System. Prepared monthly and

quarterly Quality Management System performance reports and organized and

chaired quarterly Management Review meetings.

. Participated with the identification of development constraints, and

worked with management and technical staff in performing root cause

failure analysis and implementing corrective and preventive actions to

prevent recurrence.

Avail Medical Products, Santa Ana, California 2002 to 2004

Medical Device Manufacturer, New Product Development

Senior Quality Assurance Engineer/Project Manager

. Integral member of Product Development Policy Team, tasked with

establishing the process for design control and plant transfer to be used

corporate wide.

. Successfully managed project teams to completion of new development

projects, responsible for scheduling, project plans and reporting.

. Performed Quality System Audits of new and/or potential suppliers,

participated in the qualification process.

. Established and implemented Risk Management methods and procedures per

ISO 14971 Medical Devices - Application of Risk Management and Medical

Devices. Trained all new product development employees to the process.

. Provided QA support for new product development with the development of

key documents including; quality and reliability plans, FMEA, design

reviews, verification and validation plans, product and process

validation and pilot runs.

. Managed suppliers for project teams by performing supplier assessments

and audits. Worked with suppliers to correct and improve products and

processes.

. Created and maintained Design History Files (DHF) for each project.

Respironics, Carlsbad, California 2001 to 2002

Medical Device Manufacturer, Respiratory Products

Senior Quality Assurance Engineer

. Participated as a core team member of product development teams.

. Performed supplier assessments and audits for inclusion into company

approved supplier system.

. Developed and implemented verification and validation protocols through

final reports.

. Maintained and managed non-conforming material system, including Material

Review Board.

. Coordinated and conducted failure investigations of manufacturing and

product issues to determine root cause of failure.

. Designed, developed and executed Highly Accelerated Stress Screening

(HALT) for devices and components during the engineering design phase.

. Performed MTBF calculations and reliability predictions during the design

and development phase

4-D Neuroimaging, San Diego, California 1996 to 2001

Medical Device Manufacturer, Imaging Systems

Engineering Project Manager

. Lead and participated on project teams with engineering managers to

prepare cost and schedule estimates.

. Maintained project administrative files, developed and maintained project

schedules and timelines, including initiation of project, and

identification of critical pathways, reported progress to management.

. Served as a cross-functional liaison with all relevant departments:

engineering, materials, manufacturing, business development, marketing,

quality, etc. to support the projects.

. Managed and documented, phase and design reviews including tracking of

open action items resulting from the reviews.

. Developed communication and reporting methods for project status,

including tracking of progress to schedule and areas of concern impeding

progress.

. Worked with engineers to develop documentation that complied with

corporate, quality assurance and regulatory requirements

. Established and documented the design control process and procedures,

training employees and served as a mentor to assist with the

implementation.

. Facilitated, managed and maintained engineering risk management program,

ensuring that risk management was addressed at all phases of the device

life cycle.

. Maintained Essential Requirements Matrix, Technical Dossier and Design

History Files

. Implemented and maintained customer complaint system.

. Worked with all departments to overcome obstacles hindering the

projects.

. Performed software validation on complex imaging system

. Maintained system site configuration files.

Manager Quality Assurance and Regulatory Affairs

. Responsible for coordinating, implementing and facilitating process

and procedure development.

. Managed with purchasing the supplier management processes and

improvements.

. Managed Document Control Department including device lot records and

engineering change process to be compliant in an FDA environment.

. Managed Quality Assurance and Document Control personnel, department of 6

employees.

. As QSR Management Representative held QA system review meetings with

upper management and worked with European Division in Finland, France and

Germany to be FDA compliant. This required extensive travel.

. Established and maintained internal quality system and external supplier

audit programs

. Participated in phase and design reviews, system reporting, contract

review, material review and change control boards as the QA team member.

Biosite Diagnostics, San Diego, California 1993 to 1996

Medical Device Manufacturer, Cardiac Diagnostic & DOA Diagnostic Products

Senior R&D Quality Assurance Engineer

. Established quality requirements for new medical cardiac diagnostic

instruments

. Developed and created product test and calibration procedures, methods

and flow, including training of technicians.

. Performed comprehensive analysis of requirements to determine quality

characteristics to be controlled, inspection and test equipment

requirements, special process controls and training of technicians tasked

with performing test and inspection.

. Analyzed and compiled reports of defects and failures and initiated

corrective action

. Developed and applied quality engineering theories, methods and research

techniques in the development, establishment and maintenance of quality

assurance policies, procedures and methods.

. Established sampling plans, quality standards and quality control

instructions transferred to and utilized by manufacturing, test and

inspection after product introduction.

. Developed and executed validation protocols and procedures for validation

of software and product manufacturing processes.

. Maintained all engineering documentation associated with the development

of the new product, including the Device History File, through the design

transfer phase of the development cycle.

EDUCATION

Pepperdine University

Applied Mathematics

University of California, La Jolla, California, Continuing Education

Engineering Management Certificate

Total Quality Management Certificate

Regulatory Affairs Certificate

Phil Crosby Quality College, Deerfield, Illinois

Quality Management Certificate

Train the Trainer Certificate

PROFESSIONAL AFFILIATIONS

American Society for Quality (ASQ) - CQA, CQM, CQE

Regulatory Affairs Professional Society (RAPS) - working towards RAC for

USA

Additional Training and Certifications

CQE 1996 (Expired)

CQA 2005 (Expired)

CQM 2003 (Expired)

Nelson Labs - The Science of Sterilization (5 day Course) 2004, 2011

ISO 13485 Auditors Training (Multiple Courses)

Statistics in the Medical Device Field (4 day Course) 2009

QSIT - How to Survive a QSIT Audit (3 day Course) 2006

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