Quality Medical Device

I offer guidance on Quality Management, and NPD, successfully leading

medical device companies through a risk based approach to:

. Identification of the DHF deliverables for FDA/ISO compliance;

. Remediation activities to bridge the gaps in deign control,

complaint/MDR, CAPA's Vendor surveillance requirements;

. Streamlining of New Product Development, and Production Processes;

. Training of Engineering in Quality and Productivity Improvement.

I have sixteen (16) years of result-oriented experience leading QA/RA and

NPD activities of several families of infusion pumps (electronic,

elastomeric, and syringe pumps) and sterile disposable devices from

inception to 510 (k)/ISO clearance and post-market surveillance. I have

authored procedures, created Master Validation Plans, and led the

implementation of associated V&V, and IQ/OQ/PQ protocols and reports for

the above. My expertise is in specification of content, and organization of

Quality Records (DHF, MDR's CAPA's to facilitate compliance, product

sustenance, and NDP. I have led multiple design and manufacturing

transfers, including training of suppliers, and reconfiguration of the IMS

with minimal interruption in delivery, and process performance. I offer a

strong experience in managing people, activities and schedule both during

R/D, and production using facilitation skills, and quality tools.

Education: University of Paris VII, Paris/France.

. Ph. D Probability and Statistics

. M. S. Process Control

. M. S. Engineering Mathematics

Competencies:

. Perform a Gap Analysis of the DHF Deliverables

. Provide insight to management for a risk-based approach to mitigation

. Provide design input to manage risk and engineer quality in design

. Speed up, and improve design transfer - (re)validation, IQ/OQ/PQ

. Develop 510 (k)/Technical files for submission

. Interface with Regulatory agencies (FDA, ISO, TUV)

. Perform compliance audits (CFR 820/ISO 13485)

. Improve change control, and reduce ECO processing time

. Focus complaint, MDR, and CAPA investigations where it is warranted

. Customize training in engineering, and manufacturing

. Provide feedback to manufacturing for performance improvement

. Provide input to suppliers for improved quality, cost, and delivery

. Focus resources on critical areas

. Reduce MDR's complaints, and non-conforming materials

. Guide performance metrics

Additional Information:

. Bilingual: English, French. Fluent in German.

. Open to traveling and relocation

Work Experience

January 2008 - Present, Insight Technology, Laguna Niguel, CA

Quality Consultant

Responsibility: Provide guidance in implementation, and management of a

QSR/ISO 13485 compliant quality system. Support remediation initiatives.

Accomplishments:

2012 - 2014 Successfully led the Remediation efforts for a class II medical

device company, pursuant a 2012 FDA 483 observations, and a Warning Letter

reflecting concerns in Design Control, MDR/Complaint, and CAPA

Investigations. These efforts culminated in 2014 with a No Action Indicated

(NAI) FDA Audit, closing the Warning Letter.

2010 - 2012 Designed, developed, and brought to market a family of reliable

pain management kits (mix products), including sterile disposable catheters

and pumps. Products are sold in the US market..

2008 - 2010 Established a QSR/ISO compliant quality system. Provided

guidance in the design and development, quality, and manufacturing, and

distribution of a family of reliable elastomeric infusion pumps. Sales

reached $2M the first year, in the US and EU. The company was acquired by

larger medical device company.

1998 - 2007, Curlin Medical, Huntington Beach, CA

Manager/VP/Senior VP Quality and Regulatory

Responsibility: Manage changes in engineering, design, cost, quality,

production, and delivery of infusion pumps, sterile disposable

administration sets and accessories in compliance with CFR 820 and CFR 803.

Enforce regulatory policies and procedures, so products are made, and

delivered on time, to specifications, and within budget. Company was

acquired by Moog in 2006.

Accomplishments:

. Successfully managed the QA/RA and production of Curlin Medical from

its birth in 1998 till its acquisition in 2006 without any downtime.

. Controlled costs, quality, and delivery. Built responsiveness and

agility resulting into a great reputation of quality, growing sales,

and 50% net profits.

. Kept company out of quality and regulatory troubles. Passed two FDA

audits in 2004 and 2006 without observations. CE marked two families

of class II medical devices.

. Shortened ECO processing time to hours and days when larger

competitors needed days and weeks.

. Minimized suppliers' costs, and lead time, enabling them to focus

their resources on quality.

. Managed performance, developed talents, and managed rapid growth

1988- 1998, Business Quality Services, Los Angles, CA

Quality Consultant:

. Helped Deming in his 4-day seminars. Published several papers on

Deming management methods. One of them was selected by ASQ for an

international conference in Toronto (http://asq.org/qic/display-

item/?item=3633).

. Consulted with Chevron, AMR, and PBS, supporting their quality

improvement efforts. Chevron's leak remediation project in peculiar,

involved multiple engineering companies across the US refineries and

pipelines.

. Taught and used facilitation skills, and quality tools on multiple

cross-functional projects.

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