Quality Assurance Management

MARTY SEGARI

*** * ******** ******

Anaheim, CA-92804 *******@***.***

Cell 951-***-****

PROFESSIONAL PROFILE

Innovative and results-driven Executive Management Professional with an

impressive 25-year record of success in delivering profitable growth in the

medical device and aerospace sectors. A change agent with exceptional

talents in revitalizing operations through lean manufacturing techniques,

invigorating employees through team-building and empowerment, and driving

strong and sustainable productivity gains, cost reductions and quality

improvements. A dynamic professional who is able to identify and implement

simple solutions to complex problems with hands-on, lead-by-example

management style, fostering a culture of teamwork, shared mission and a

dedication to excellence.

PROFESSIONAL SPECIALITIES

Mastery of Quality Management Systems (ISO 13485, CFR 820 QSR, ISO 9001,

AS9100, ISO 14971, IEC 60601, ISO 10007, MDR, CMDCAS, CMDR); Manufacturing

Execution System (MES) and Electronic DHR; AGILE Configuration Management

System and Document Control; APQP, PPAP, IQ/OQ/PQ Validation, P&DFMEA,

Process Control Plans, Environmental Management System (ISO-14000, RohS /

REACH); DFX planning; Lean Six Sigma; Manufacturing / Test Engineering;

Configuration Management; Complaints/CAPA management and regulatory

reporting.

PRODUCT TECHNOLOGIES SUPPORTED

Medical devices (Class I, II and III) - Aviation and defense products -

Computers and Consumer Electronics -

Industrial Electronics and Systems

PROCESSES

Mechanical / Electro Mechanical Assemblies and Systems -Printed Circuit

Board Assemblies (Through Hole, SMT, COB, BGA etc.) - Cable / Harness

Assemblies - Plastic Injection Molding/Hybrids - Precision Machining - In-

Circuit and Functional Testing

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PROFESSIONAL EXPERIENCE

Independent Consultant 9/13 -

Current

FAA, DOD, FDA, ISO Based Quality Systems, Quality/Reliability Engineering,

CAPA/Complaints Management, Design Development Process/NPI, Process

Validation, Supplier Quality Assurance, Quality Assurance/Control, Product

Configuration Management, Metrics Development / Deployment, Remediation

Projects, Auditing (ISO 9001:2008, ISO 3485, AS9100)

Biolase, Inc. (Medical Device)

12/12 -7-13

Director of Quality and Regulatory Compliance and Management

Representative. Responsible for quality assurance and FDA compliance

activities throughout the product realization cycle including post market

surveillance. Directly involved in the complaints handling, trending,

regulatory reporting, CAPA management and auditing.

Restructured the quality organization to ensure efficiency and

effectiveness; Performed a gap analysis and initiated actions to fix

deficiencies and obtained ISO 13485 recertification and passed FDA

inspection; Developed the supplier quality charter and global audit

schedule to develop supplier base; Initiated RoHs / REACH conversion plans;

Developed and conducted a comprehensive management review that was well

received by the leadership team; Developed a metric driven culture within

the Quality and operations. Personally led the post market surveillance

activities including trending, investigations and CAPA.

Masimo Corporation, Irvine, CA (Medical Device)

1/11 - 11/12

Senior Director of Quality Assurance: Responsible for Quality Systems,

Quality Engineering, Supplier Quality Assurance, Quality Assurance

oversight across all manufacturing sites / distribution centers and

reliability engineering. (Acting head of QA for 18 months until the VP of

QA was hired.)

Developed the procedures and processes for getting ISO 14000 certification;

Developed the plan for RoHs / REACH implementation; Developed the Quality

Systems Engineering charter to improve effectiveness of Quality System;

Developed the supplier quality charter and global audit schedule to develop

supplier base.

Automated the product hold and stop ship process; Established reliability

engineering charter and put in place HALT/HASS system to improved product

and process robustness; Established quality agreements with key suppliers

and implemented a comprehensive New Product Introduction process at

supplier sites to successfully outsource 48 PCBAs;Developed a better

quality reporting system to drive measurable improvements; Launched several

new products onsite and at suppliers globally, specifically in Asia;

Developed and implemented a QA test lab to independently verify product

conformance to requirements. Provided design / quality assurance support to

the successful release of 4 new Systems (Pulse Oximeters and Brain Function

Monitors) and 28 cable/sensors.

Esterline Power Systems, Buena Park, CA (Aerospace/Defense)

7/08 - 1/11

Senior Director of Quality Assurance and Operations Engineering (Head of QA

and RA)

Responsible for the Site Quality Systems, Quality Engineering/

Qualification Test Labs (QPL), Supplier Quality Assurance, Post-Market

Quality Assurance / Service Center/ FAA Approved Repair Station, Quality

Control, FAA- PMA Management including the management of Manufacturing/

Process/ Industrial Engineering /Health, Safety and Environmental

Engineering functions

Achievements:

Developed an overall QA organizational structure to better support the

needs of the internal and external customers and aligned the organization

to the company's vision, goals and objectives; Implemented a Post Market

Quality Assurance charter to comprehend the Material Service Center, the

FAA approved Repair Station and Failure analysis departments; Developed a

supplier quality assurance charter and staffed it to drive results;

Overhauled the Quality Management System processes and procedures by

eliminating non-value adding processes and procedures; Established a formal

Quarterly Management review of the company's performance including the

effectiveness of the Quality Management System with all executive and

senior management; Established a cross functional Failure Review Board (

FRACAS) for periodically assessing market product quality issues and

factory quality trends and driving design, process and material changes to

improve the reliability and initial quality of our products; Established

within the QA department a performance management system that is aligned to

the company's flight plan goals and objectives; Centralized all Quality

System Procedures for online access to all employees; Improved performance

across supplier base, in-process quality, Quality System, Post Market /

customer Quality

VIASYS HealthCare Corp (Cardinal Health/ Carefusion) -(Medical Device)

03/05- 6/08

Director, Quality Assurance and Regulatory Compliance

Responsible for proving the leadership and management of SensorMedics,

Bear Medical and Bird Medical SBUs Quality Systems, Quality Assurance

/Engineering, Supplier quality Assurance, Failure Analysis, Complaints &

CAPA Functions and continuous Improvement ( Six Sigma &TQM) activities.

Member of the Respiratory Care Total Quality Executive Council. Chairman of

the CAPA Board and Vice Chairman of the Quality Review Board. Mentored and

facilitated Six Sigma / Lean-5S Teams as the site Black Belt. Went through

2 FDA inspection without any 483 findings

Achievements:

Reduced MRB Inventory from $1.5M to less than $150K in one 2 years;

Improved overall First Pass Yields ( 6 product lines) from 60% to 95% in 2

years; Reduced receiving inspection backlog from $1.2M to less than $150K

in one year; Reduced average receiving inspection backlog aging from 2

months to 3 days in 1 year.

Reduced complaints backlog from 5000 to less than 1000 in two years.;

Reduced CAPA response time from 3months to 30 days;Reduced Out of Box

Failures at install from 5% to .7% ( rolling 3 months average)

Maintained the quality system performance of the operation without any 483s

or warning letters from FDA; Established Cross functional Quality Review

Boards to drive operational excellence; Improved many elements of the

quality systems including the CAPA / Complaints system to drive the close

loop corrective action system; Restructured the QA/RC department to handle

the revenue growth and reduce the backlog of inbound material and customer

complaints; Implemented process audits and out of box audits to improve

internal and external first pass yields; Implemented the first ever HASS

program for one of the new product prior to first shipment; Implemented an

extended burn-in program for some products to improve product reliability

and drive design improvements.

Capstone Turbine Corporation (Chatsworth) - Power Systems

10/03 - 02/05

Vice President, Quality and Regulatory Affairs

Responsible for the Quality Systems, Quality Assurance/Control, regulatory,

reliability, Supplier Quality Assurance, Field Quality Functions and

continuous Improvement activities.

Achievements: Re-established the defunct ISO-9001:2000 Quality System and

obtained re-certification; Established the charters for the quality

functions and staffed them accordingly; Established field reliability

reporting system and a closed looped corrective and preventing action

process. Achieved 5X improvement in product reliability; Established

business metrics and an executive Dash Board for cost, quality and

delivery; Reduced the Cost of Poor Quality by 25% in one year;

Established the Supplier Development, part and process certification

processes and conducted the first supplier symposium for the company.

Improved supplier quality performance from 40% to 84% acceptance; Led the

company-wide TQM and 5S implementation programs; Established the required

data collection systems to measure field and factory performance(MTBF,

Trouble-Free-Startups, Customer Satisfaction, FPY, RTY, PPM, COPQ)

Quality Management Consultant

10/02 - 9/03

Development of Quality Management Systems, product qualification plans,

Quality Plans and FMEAs; Six Sigma Tools Training; Process Re-engineering;

Supplier Development and Certification; Auditing and development of

metrics.

Worked with clients in the aerospace and consumer electronics

industries.

Thales Avionics In-Flight Systems (Aerospace)

7/98- 10/02

Director, Quality and Regulatory Affairs (Reported to the CEO)

As the head of QA and RA was responsible for the quality and

regulatory functions throughout the product realization cycle including

post market quality functions.

Accomplishments:

1. Implemented AS/ISO Quality Management System and obtained

certification in 18 months.

2. Obtained Quality System approval from AIRBUS and Boeing based on

Aerospace Quality Standards (AS 9100) and obtained product

offerability.

3. Established a team-based systematic corrective and preventive

action system that turned around the poor product performance in

the field and the customer perception.

4. Successfully led the company to outsource many of the non-core

competent work to Mexico and Asia and realized $4-5M in cost

reduction through the establishment of a structured supplier

development program.

5. Implemented paperless WEB based document control,

Corrective/Preventive Action and training systems.

Universal Electronics Inc.

6/97 - 7/98

Director, Quality and Manufacturing Head of QA.

Responsible for Quality Systems, Quality Assurance (H/W&S/W), Reliability,

continuous Improvement and supplier development/ Control functions.

Responsible for managing the global supplier base and CMs and all NPIs.

Accomplishments:

Helped the company to outsource all manufacturing activities to Asia.

Realized Savings: $10M

Established the supplier quality assurance program with SIX SIGMA emphasis

and appropriate performance measurements; Periodically audited the

suppliers throughout Asia and maintained Dock-To-Stock status for all

suppliers; Established the concurrent engineering-based toll-gated Product

Development and NPI process; Initiated the electronic document control

system by procuring and implementing the AGILE PDM system.

Mitsubishi Consumer Electronics Inc. (Braselton, Georgia)

8/95 - 6/97

Director/ Manager, Total Quality Assurance

Responsible for Quality Systems, Quality Assurance/Control, regulatory,

reliability, Supplier Quality Assurance Functions and continuous

Improvement activities.

Accomplishments:

Led the plant wide effort, as the Management Representative, to obtain ISO-

9001Certification; Establishing a set of operational metrics ( COPQ,

Delivery and Cost); Implementation of plant wide Total Quality Management

that realized significant cost savings; Established Supplier Certification

Program. Increased Dock to Stock Suppliers from 50% to 90% and 50%

Reduction in in-process rejects rates in 1year with 70% Reduction in

inspection activities. MRB inventory reduction from $1.5 M to $150K;

Established the plant wide document control / distribution (Paperless)

system utilizing Netscape and an automated Quality Data Collection system

that was adopted across all manufacturing plants.

Allied Signal, New Product Operations (Aerospace and Defense) Vista /

Sylmar, CA 7/88 - 8/95

Technical Services Manager: Responsible for managing the Test, Quality,

Manufacturing Engineering and product Configuration Operations.

Business Unit Manager: Led a business unit of 50 personnel within the

manufacturing operations from planning through delivery of the first few

systems to DOD, US NAVY on time. The activities included planning,

procurement, manufacturing operations and other support functions. Led

the on-site Six-Sigma OPEX Program and managed five green belts.

Accomplishments:

Generated two major manufacturing proposals that won multimillion-dollar

contract awards from NAVY.

Initiated, proposed, planned and implemented acquisition of new

manufacturing facility to cater for the production of the above programs;

Working with DOD personnel, obtained MIL Q -9858A and MIL STD 2000 and

SPC certification for the above facility; Promoted several continuous

improvement activities through team-based structure, facilitating and

leading the teams to successful completion of the projects providing

excellent results in throughput and productivity; Realized savings:

$300K / year

Implemented SIX SIGMA programs that resulted in 5X reduction in Cost of

Poor Quality in 6 months. Realized Savings: $200K / Year

Various engineering and management positions

1980 - 1988

(Test engineer, manufacturing engineer, Manufacturing manager,

Engineering Services Manager)

EDUCATION / CERTIFICATION

BSEE - MSEE (Completed Requirements) - Certification in TQM; Certification

in Six Sigma (AlliedSignal Black Belt); Certification in ISO-9001:2000 / AS

9100 Lead Auditing; Certification in Lean Manufacturing

MBA (Partial)

Technical Expertise

IPC 610, IPC 620, IPC 700, IPC-CH-65,J-STD, JEDC and EIA Standards,MIL

Standards

AWARDS

Total Quality Award / Allied Development of semi automated risk

Signal release control

Total Quality Award / Allied Cycle time reduction and productivity

Signal TB-23 Sonar Program

Total Quality Award / Allied Cycle time reduction and productivity

Signal SQR-19 Sonar Program

OTHER

Previous Federal Security Clearance

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