PROFILE: Extensive knowledge and experience in Medical Device

Manufacturing and Development with a concentration on medical device risk.

Quality Engineering and supplier quality engineering experience involving

complex federally regulated products, procedures, research program

management, manufacturing process technology design and implementation.

Managed and trained Integrated Product and Six Sigma teams resulting in

significant cost savings, and significant efficiency increases. Performed

vendor audits, qualifications and product failure investigations. Technical

and research writing, preparation and delivery of high level presentations,

reports, documentation and research analysis.

HIGHLIGHTS OF QUALIFICATIONS

Risk Management Training Plan Development/Cross

Training

Design Verification and Validation Clinical Affairs/External Validation

Integrated Product Team Leader Corrective Action Board Programs

Quality Engineering ISO 9000 Certified Auditor

Supplier Audits and Qualifications FDA, DOD and FAR Regulations

Compliance

Manufacturing Process Hardware Management Tead

Development/DTP

Qualified Six Sigma Specialist MRB Authority, GMP. GLP, GDP

Product Development Process Implemented Lean and Agile Initiatives

PROFESSIONAL EXPERIENCE

Ventana Medical Systems

June 2006- Dec 2009

Sr. Quality Engineer/Development

AAMI Quality Systems Certified

June 2008

Sr. Quality Engineer/Risk Manager for Molecular Probe Product Development

and Detection teams. Quality Core team member responsible for assuring

compliance to the Ventana Quality System. Signature authority regarding

approval of development documentation and protocols that will be submitted

to the FDA for future 510K/ PMA approval. Additional responsibilities

include authoring risk management plans, dFMEAS, pFMEAs, HAMs, sFMEAS,

design and development plans and stability protocols. Required extensive

knowledge of the product development process, encompassing Design

Verification, Validation and Process Validation. RESULT: Launched several

new products with significant sales and growth opportunities in the

millions, worldwide.

Raytheon Missile Systems Company

June 1999 - 2006

IPT Lead/Sr. Quality Engineer

Quality Systems Certified Auditor

Sr. Quality Engineer and Multi-Missile Factory Integrated Product Team

Leader for Joint Stand-Off Weapon (JSOW). Responsible for product quality,

reliability and assuring products met contract specifications. Hardware

Management Team Lead for electrical harness systems, and responsible for

critical supply chain activities. Chair of the JSOW monthly Corrective

Action Board. Held Material Review Board authority, and was Quality

Representative for Change Control. . RESULT : Lead of the JSOW team that

helped Raytheon win the University of Utah's Shingo Award for excellence in

Lean Manufacturing. Also lead the team that facilitated JSOW's win of the

Raytheon's Operations Program of the Year Award for two years in a row.

Gained the program exceptional customer satisfaction with the Navy and Air

Force. Weapon cost was decreased by approximately 100K/unit which resulted

in further product contracts as well as joint cost avoidance and cost

reduction activities.

Quality Engineer for Process Composites, Ultra Precision Fabrication and

injection molded products. Responsible for Product Quality on several

Missile Systems programs, including SNADS, Land Combat, and Air to Air.

Conducted monthly PPV audits, chaired Corrective Action Boards and was main

DCMA contact. Served on Integrated Product Teams, and implemented root

cause and corrective action assessments. RESULT: Previously this factory

did not have a designated QE and had constant product quality issues. Upon

implementation of quality initiatives, the Composites and Fabrication

factory became a world class facility.

Performed on the Raytheon Six Sigma Government Property team focused on

record accuracy. Developed extensive training program to educate thousands

of employees on handling government property. Produced training video,

coordinated awareness campaign and assured each employee was trained by

management flow-through. RESULT: Prevented government disapproval of

property system, reduced property held due to errors by 67%, reduced

material movement by 28 miles, decreased cycle time by 80%, and generated a

cost avoidance of approximately 13 million dollars.

Abbott Laboratories, Abbott Park, IL

Jan 1993-1999

Quality Engineer/Biochemist

Originated search for alternate vendor of polystyrene immunoassay beads

manufactured by injection molding for several diagnostic products, assured

vendor compliance, performed vendor failure analysis and audits, conducted

experiments, generated and interpreted data, wrote and approved document

changes and implemented the alternate beads into the assay system. RESULT:

New bead component was qualified for 35% of Abbott's bead assays, reducing

overhead, increasing profit margin and first-pass acceptance rates from 40%

to over 90%.

Established protocols for approving sensitivity panels for diagnostic

products. Designed and performed experiments, generated and analyzed data,

wrote extensive documentation for manufacturing testing of these materials,

stabilized manufacturing and testing process. RESULT: Assured quality

products on-time, maintained product availability, reduced compliance

risks, increased team efficiency and simplified whole panel manufacturing

and testing process.

Studied human body immune response to Chlamydia, Gonorrhea, Hepatitis,

HIV/AIDS, cancer markers, Strep, HCG, Rubella and CMV/Cytomegalovirus to

assist in development of detection assays utilizing manual, semi-auto and

full-automated testing devices. RESULT: Added additional products to the

Abbott diagnostic line, increasing profit margin by millions of dollars.

Oversaw production line of TestPack Chlamydia, including coordinating

production and troubleshooting runs, identifying process improvements,

developing extensive training plan, streamlining operations, resolving

production and operation issues and writing production documents. RESULT:

Increased productivity, generated higher quality products, minimized cycle

time and improved first-pass acceptance rates.

EDUCATION

Certified Quality Engineer, currently enrolled

AAMI Design Control Course, October, 2009

AAMI Risk Management Certification, June 2009

AAMI Process Validation Course, January 2009

AAMI Quality Systems Certified, June 2008

Raytheon Global Leadership Program, August 2005

Thunderbird, The Garvin School of International Management

Raytheon Project Management Certification Program

Raytheon Missile Systems

MBA/GM (2001)

University of Phoenix, Tucson, AZ 85712

BA (1993)

Carthage College, Kenosha, WI

Major: Biology

Minor: Chemistry

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