Quality Engineer Manager

CAREER SUMMARY

Currently looking for a position in teaching or desk audit that will utilize my broad experience for supplemental income.

Experienced Quality Management Director successfully driving QMS development, training, and maintenance.

My resume, encompassing more than twenty years’ experience including ISO 13485 Quality Management System implementation, FDA (Design Controls) and DOD regulated industries. My broad background in nursing, medical device, engineering and business has served as a basis for successful program, project, and team management. Having this diversity facilitates communication and strategic thinking / decision making. DOD experience required Secret clearance.

QUALIFICATIONS

Standards: strong understanding and process implementation per ISO 13485:2016 and 14971:2012, ANSI/AAMI/IEC 62304:2016, IEC 82304-1:2016, FDA regulations, and AAMI/IEC 62366.

ASQ Certifications: CQM/OE (Certified Quality Manager / Operational Excellence), CQA (Certified Quality Auditor), CSQE (Certified Software Quality Engineer).

HIPAA Certifications: HIPAA Security; HIPAA Awareness for Business Associates

Clinical Certifications: NIH: Protecting Human Research Participants; CTN: Good Clinical Practices

Early experiences: Teaching robotics to children in a gifted program for grade school students.

Previous experience working in a DOD environment with a Secret level clearance.

Employment History:

Owner – Hillcrest Lodge – 2020 – Present

Hillcrest Lodge, 40241 Big Bear Blvd., Big Bear Lake, CA 92315

Phone: 909-***-****

Web Page: www.hillcrestlodge.com

Actively involved in all aspects of the business.

Independent Contractor – 2016 – 2021

Multiple companies, Class II and Class III devices, work included:

Acting Director of Quality in start-up environments / Management Representative

Development, training, and reporting at a new bay area SaMD team in a large corporation. Processes implemented in accordance with IEC 62304 and 82304 2016

Creation and/or improvement of QMS systems in compliance with ISO 13485:2016, ISO 62304:2016, and FDA QSR’s and ISO 9001 resulting in successful EU certifications with remediation plans

Timely Supplier audits domestically and internationally conducted achieving company development / production plans

Team training on multiple Quality System topics to drive optimized compliance.

Complete Genomics, Inc. – (1/2014 – 1/2016)

Title: Manager, SWQA (Genetic sequencing)

Built and managed a Software Quality Team resulting in improved software reliability as measured by a reduction in complaints from the operations and development teams.

Strategic implementation of an ALM system based on research and ROI data to drive process efficiency.

Developed and provided training on SW related regulations and standards to educate developers and quality team on the regulations impacting software.

Palmaz Scientific, Inc. – (8/2013 – 1/2014)

Title: Quality Assurance Manager / Management Representative

Successfully addressed previous audit findings to lead the BSI Surveillance audit as the company management representative in September, 3 weeks after joining the staff. The results of this activity was passing the surveillance audit with BSI citing that the recent work and changes implemented by the new QA Manager directly impacted the successful completion of the audit.

Hansen Medical – (3/2010 – 8/2013), Class III device

Titles: System Verification Team Leader with direct reports, 9/2011 to 8/2013; Staff Verification Engineer 2/2013 – 8/2013; Project Core Team Member (2 project teams), System Verification 7/2011 – 8/2013; CCB Chairperson for EP product line 8/2011 to 8/2013

Strategic reorganization of the SW processes for compliance to ANSI/AAMI/IEC 62304:2006 resulting in a more consistent product delivery.

Strategic creation and executed multiple System V&V Plans for existing and new products, coordinating the use of limited systems for various internal and external test cycles for efficient use of test resources both human and product.

Independent Contractor – (8/2007 – 2/2010)

Multiple Companies, work included, Class II devices:

Normalized the SW Life Cycle Process with ANSI/AAMI/IEC 62304 and provided leadership on FDA 510k submission paperwork, guiding follow-up responses to the FDA

Company preparation for external Quality System audit; perform clinical, design, and V&V plan review.

Tyco Healthcare, Respiratory (now Medtronic) (1/06 – 7/07) Class II devices

Strategic gap analysis and plan development to allow release of product on hold by the US FDA.

Multiple audits and strategic corrective action plans worldwide.

Travel requirement at least 50%.

The EmTek Group (4/04 – 12/05)

Title: Manager, Quality Systems

Developed and implemented QMS with flexibility to work with a client’s in FDA and NRC regulations, including a CAPA system.

Revivant Corporation (now Zoll Circulation) Class III Device (5/02 – 9/03)

Title: Manager, Systems Quality Assurance

Verification planning, design and execution including a product life test that allowed correction of a weakness before it manifested in the field.

Symphonix Devices Inc. (now MedEl, Austria) (8/98 – 3/02) Class III device

Title: Program Manager – External Devices; Project Management – Device Development

Program management for external contract development of multiple products simultaneously resulting in elimination of unnecessary tasks and overall cost reduction.

Planning and implementation of all V&V activities to clear class III device through FDA and EU.

LifeScan, Inc. (J&J division at the time of employment) Class II device

Title: Manager, V&V, Manufacturing Engineering (4/96 – 8/98)

Created a V&V process that integrated with the software development process and enhanced the reliability of manufacturing line software based on FDA Design Controls.

Build / managed V&V team with 0 turnover in resulting in recruitment cost savings.

Education:

State University of New York, Polytechnic Institute (SUNY Poly)

M.S. Management Science

B.S. Computer Science

Other, Oneida County Board of Cooperative Educational Services (BOCES)

Diploma Practical Nursing; Licenses: New York State, New Jersey

Other, UCSC Extension Regulatory classwork: (1) Regulation of Medical Devices and Diagnostics, (2) Interacting with the FDA, (3) Post Market Regulatory Requirements, (4) Design Controls, (5) Regulation of Drugs and Biologics.

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