CQE, MSEE Resume

Title
CQE, MSEE

Primary Skills
QS management, CAPA/Complaint resolution, Supplier Q, Risk mgmt, etc.

Location
US-CA-San Mateo (will consider relocating)

Posted
May-05-09

CQE, MSEE

Career Objective:
To be exceptionally effective in identifying and solving technical problems with medical devices, by building and managing robust, compliant, and profitable quality systems.

Why me?
After decades of experience, many aspects of medical device quality systems management and regulatory compliance have been mastered. I have an especially strong history of resolving product problems, as a compliance system designer, manager and individual contributor. I possess broad engineering expertise, with many successful endeavors to my credit, including the recent development of a particularly incisive complaint system at Apieron, and building an ISO 13485:2003 quality system at Radiant. I can readily accept lead responsibilities for CAPA, Complaints, Supplier Quality, Compliance Auditing, Risk Management, and New Product Introduction QA. I have studied marketing extensively, am always sensitive to business fundamentals. I pride myself on being a champion of highly compliant quality systems, product improvements that financially deliver, and advances in the state of humanity. I am currently available due to financial difficulties at Apieron.

Work Experience:
Apieron, Menlo Park (September 2008 - April 2009): Senior Quality Engineer
With strong inter-departmental collaboration, I greatly upgraded the complaints system and reporting, bringing a wayward system with poor closure rates and communication abilities into fine tuning. Additionally, I managed the instrument fraction of the CAPA system, two field actions, and Supplier QA, as well as support of production and product development.

Oraya Medical, Newark (May-June 2008): Quality Engineer
Contract position to evaluate commercially available requirements management software, and prepare procedures in an early-stage development environment

VIP China, PRC (Sept 2007-Feb 2008): English Teacher, Entrepreneur
A self-imposed sabbatical to explore China, including teaching English in rural Yunnan, assisting an agency that recruits English teachers, and working to create rare fruit orchards.

Radiant Medical, Redwood City (2006-2007): Senior Quality Engineer
1) The solitary QE in a pre-IPO environment
2) Primary responsibility for most QA issues surrounding production and development of an intravenous cooling system
3) Primary responsibility for constructing and managing the CAPA, Complaints, Supplier Quality and Risk Management systems, that resulted in favorable ISO 13485:2006 certification.

Boston Scientific, Electrophysiology, San Jose (2001- 2006): Senior Quality Engineer
1) Senior QE in a massive revalidation project, involving all disposable product lines.
2) Leader of a project to evaluate a complex catheter that had been recalled.
3) Primary QE for introduction of a new radio frequency generator/controller, as well as several catheter projects.
4) Ongoing support for labeling, ISO safety and EMC testing.
5) Led safety compliance effort for several legacy catheters and systems
6) Broad professional training.

Somnus Medical Technologies, Sunnyvale (1998-2001): QAE, then Senior QAE, then Quality Improvement Manager
1) Complaints systems management, failure analysis and resolution, customer responses, MedWatch reports, management reports, CAPA Board leadership, FDA/ISO audit resolution.
2) New product introduction QA, shelf life, biocompatibility, FMECA, MDD checklist, s/w coding and validation, process validation, special marketing projects, trade show participation, two invention disclosure bonuses, transition team in sale to Gyrus PLC.
3) Receiving inspection management of two inspectors, change control, material review.

Laserscope, San Jose; Cardiometrics, Mountain View; Accuson, Mountain View; Nellcor, Hayward; Varian Associates, Palo Alto (1987-1998): Various medical device quality engineering positions
Experience at these medical device companies included supplier development, product introduction, Complaint resolution, product validation, team leadership, ultrasonic imaging, DFU's, product transfer after sale, technical documentation, reliability, production support, CAPA and failure analysis, and durable equipment refurbishment.

Varian Associates, Palo Alto; EG&G, San Ramon; Hughes Aircraft, Torrance (1978-1987): Vacuum tube engineer
Microwave tube and CRT design, development, and production, including magnetic design, testing, failure analysis, coolant systems, vacuum arc abatement, high speed oscilloscope technology, braze fixturing, pyrolytic carbon deposition, and vacuum systems.

Education:
MSEE (1981) and BSEE from SUNY at Buffalo, New York: emphasis on power devices, arc plasmas, electromagnetics, and systems.
Other university classes since graduation in biomaterials, laser physics, ultrasonic technology, several marketing courses, applied statistics, and quality engineering. Other learning includes dozens of seminars and internal training sessions on QA technology, electrophysiology, meeting management, sales, cardiovascular systems, project management, true positioning, software QA, catheterization lab procedures, plastics, time management, regulatory issues, etc. TEFL certificate.

Other significant associations and features:
o Senior Member of the ASQ and Certified Quality Engineer (CQE).
o Certified ISO 13485 Auditor.
o Past Chair and current Board member of ASQ Biomedical Division Northern California Discussion Group.
o Current Board member of the California Rare Fruit Growers, Santa Clara Valley section (crfg.org).
o California licensed foster parent.
o President of Golden Doorway Inc., a firm with interests in China.
o Modest but growing Spanish and Mandarin language abilities.
o Lead inventor in medical device patents (pending) 20070191829 and 20070191830

Certifications
CQE, MSEE, ISO 13485:2003 Auditor (might have lapsed...)


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