Manager Quality

Executive Summary

Commitment Leadership Integrity

A proven visionary and strategic leader who translates business strategies into the best interest of shareholders, customers, and employees. Accomplished and result-driven Quality and Regulatory Affairs professional with over 15 years of experience in the Medical Device and Drug industry, along with over 20 years of leadership experience, additionally experience with project management and process improvement (SixSigma and lean manufacturing certifications).

Areas of Expertise

Quality & Regulatory

Product Life Cycle

Business Development

ECO’s

Document Control

End Of Life Process

Operations Management

People Management

Process Improvement (Six Sigma)

Product Introduction

CAPA process & Resolution

ACCOMPLISHMENTS

Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guidance documents. Systems included design and document controls; verification and validation; complaint handling; CAPA processing; training; internal audits; supplier controls; environmental monitoring; incoming/in-process inspection, final acceptance and stability testing

Developed processes for supplier management and completed supplier approvals and audits of contract manufacturers, test labs, and key suppliers. Completed on-site inspections of suppliers manufacturing and quality systems, resulting in process improvements and improved relationships.

Provided leadership and direction for the Quality Assurance department, including Document Control, Audit, Quality Control and CAPA Management systems utilizing risk management tools such as FMEA, fish bone and other ISO 14971 requirements. Supervised, both exempt and non-exempt personnel, including; hiring, performance appraisals, salary reviews, coaching/mentoring, and disciplinary issues.

PROFESSIONAL EXPERIENCE

Author-it July 2015 – March 2016

Sr. Manager, Quality and Compliance

Software Development Company, Seattle, WA

Develop and implement a Quality Management System for the Life Science Industry

Conduct global QMS training for all employees

QMS compliant with ISO 9001, 27001, and FDA regulations for a SaaS company

Responsible for responding to customer audit observations with emphasis on Data Security and Data Retrieval

Responsible for Quality Committee meetings

Conduct gap analysis on product lifecycle and policies/procedures

Participate in Software Product Development Meetings

Participate in Customer Focus Innovations and meetings

Health First

Regulatory and Quality Assurance Manager Oct 2014 -- July 2015

Small Device Company in Mountlake Terrace, WA

Host and manage external audits from FDA, DEA, Board of Pharmacy (BOP)

Responsible for State registrations and FDA and DEA establishment registration for drugs and devices

Schedule and perform internal audits

Annual reporting to federal and state agencies including, Sunshine, Inventory controls, drug distribution, compliance assessments

Maintain Quality System (Document Control, CAPAs, Complaints, Audits and Training)

Conduct new employee training and periodic cGMP training

Responsible for periodic reporting to state boards

Responsible for drug distribution and reporting (FDA Part 210 and 211)

Set-up UDI and DQSA structure for FDA requirements

SPACELABS, ISSAQUAH, WA Mar 2012 – Oct 2014

Medical Device Company

Global Quality Systems Sr. Manager

Maintain Global Quality Systems (Document Control, CAPAs, Audits and Training) in all our global locations

Participate in general Quality Meetings and Annual Management Review Meetings

Review Engineering Change Orders (ECOs) using our electronic Document Control System-Agile

Conduct global training

Provide support and direction for monitoring and conducting annual internal and external audits

Provide direction and feedback to documentation control personnel

Provide support to Change Control Board Meetings

Prepare and conduct site-wide training program related to Quality Systems and cGxP’s

Actively manage a group of employees which would include performance evaluation, job assignment and group development

Hosted and participated in external audits

Developed and established a global training record program

Create and conduct Protocols/Validations

BAYER, LYNNWOOD, WA Oct 2010 – Feb 2012

Active Protein Ingredient Drug Company

Quality Assurance Compliance Manager Consultant

Maintain Quality Systems

Provide support and direction for accomplishing annual internal and supplier audits

Responsible for document control, including, archiving, filing, annual document reviews and setting metrics

Establish and lead Change Control Board Meetings

Prepare and conduct site-wide training program related to Quality Systems

Actively manage a group of employees which would include performance evaluation, job assignment and group development

Developed and established a training record program

STRATOS, SEATTLE, WA Nov 2009 – Oct 2010

Design and Development Company

Quality and Regulatory Consultant

Establish Quality System to be FDA compliant

Review MDD requirements with clients

Gap analysis and implement Quality System and procedures for ISO 13485 compliancy

CAPA analysis and restructure

QSR and ISO 13485 Training for management and employees

Internal audits

Make recommendations for regulatory strategy with new clients (Class I, II and III devices)

Implement new training program for new and existing employees

GENERIC MEDICAL DEVICES, INC., GIG HARBOR, WA June 2007 – Aug 2009

Start-up Company specializing in Urology and other Class I and Class II implantable devices.

Regulatory Affairs and Compliance Manager

Establish quality system related procedures and policies for Regulatory Affairs

Provide guidance in complying with regulations; assist in developing rationale and documentation for new product development, product changes, testing, design reviews, and labeling reviews.

Risk Hazard Analysis (ISO 14971:2007)

MDD requirements review and implementation

Product Registrations with international agencies

Interface with FDA on regulatory issues; Interface with international regulatory agencies

Supervise the activities Regulatory Affairs Personnel

PHILIPS MEDICAL SYSTEMS, BOTHELL, WA Apr 2001 – June 2007

Manufacturer of Class II and III Medical Devices: Cardiovascular Imaging, Magnetic Resonance Imaging, X-ray, CT Scanner, Ultrasound, Nuclear Medicine and Patient Monitoring

Senior Regulatory Affairs Specialist

Responsible for Quality Assurance and Quality Control for three US sites; conduct and document internal audits for continued process improvements and compliance

Pre-screen all field problem reports (complaints) submitted for risk analysis

Responsible for gap analysis, business requirements and budgets for SAP (ERP platform) integration and migration

Submit monthly recall status reports and MedWatch (MDRs) reports to the FDA within time requirements

Conduct internal and external audits

Maintain country registrations to meet regulations for submissions, exports and licensing requirements

Create training curriculum and conduct training for call center and new employees on complaint procedures

Responsible for identifying and implementing Field Change Orders for North America (engineer changes/upgrades made to medical equipment)

Assure that all FCOs are implemented within the time frame allowed by the manufacturer

Evaluate and rewrite Field Change Order Process and Requirements for the United States

Influence regional offices in implementation of changes and establish weekly/monthly metrics

Establish Financial Key Performance Indicators (KPIs) for the department and field personnel

Provide monthly KPIs to senior management

Created website for field engineers to efficiently manage and reduce service calls

EDUCATION

1996-1997 Computer Programming Bellevue Community College

2002-2003 Certificate in Biomedical Regulatory Affairs University of WA

2004 Green Belt Training, Certified (Six Sigma) Philips Medical Systems

2009 ISO 13485 Lead Auditor Certified ASQ

2012 Regulatory Affairs Certified RAC (RAPS)

2012 Agile PLM Training Oracle

2012 CMDR Training RAPS

PROFICIENT

SAP MNP, PR1, MP1 environments, Lotus Notes, MS Office, MS Outlook, MS Project/Front Page, HTML, Internet Explorer, Agile, ComplianceWire (UL company), Assurx, Oracle (Agile), SharePoint

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