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Quality Assurance

Location:
Jersey City, New Jersey, United States
Posted:
May 20, 2018

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Resume:

MARTY SEGARI

ac5i8g@r.postjobfree.com

714-***-****

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

PROFESSIONAL EXPERIENCE

Independent Consultant- Aerospace and Med device organizations 2/16 – Current

Main focus on Design Assurance and Quality Engineering

KavoKerr: (December 2017 – current)): Senior Design Assurance Engineer

KavoKerr: (7 Months) – Design Assurance Engineer - Design Assurance support for new product design and design transfers. Introduce new product design at manufacturing sites.

Lasergen (San Diego): (4 weeks) Support product development as the key design assurance engineeer. Development, review and approval of MRD, PRD and RAMM documents.

Fresenius: Design Assurance Engineer ( 3 weeks)

Event Medical: ( 2.5 Months) Managed QA and RA functions.

KavoKerr: (8 Months) – Design Assurance Engineer - Design Assurance support for new product design and design transfers. Introduce new product design at manufacturing sites.

Specific activities/tasks include Risk Analysis, DFMEA, PFMEA, Test Methods Development and Validation, Review and Approval of DRS, ERS and TPS as part of Design Control Processes, review and approval of Sterilization, packaging validation protocols and test reports, review and Approval of IQ/OQ/PQ protocols and test reports, providing program support for Electrical safety, EMC and RoHs/Reach/WEEE, providing guidance with respect to Software Development Lifecycle Processes – FPGA and supporting 510K submission documentation needs.

TMC - Corona (2 months): Develop and improve existing QMS and QA Processes.

Specific activities/tasks include Developing / Streamlining Factory QA procedures, establishing the defunct Quality System processes and developing / implementing customer specific visual schedule management tools.

Rapiscan Systems Inc. (X-Ray Systems) 8/13 – 10/15

Senior Director of Global Quality Operations: Responsible for Quality Systems, Quality Engineering, Supplier Quality Assurance, Design Assurance, Quality Assurance oversight across all global manufacturing sites. Developed and implemented a set of global policies based on FAA, DOD, FDA, and ISO Based Quality Systems. Some of the specific accomplishment are as follows: Developed Process Performance Qualification/validation protocols for new product design transfers; Developed and implemented reliability improvement programs; Streamlined the CAPA/Complaints Management process; Developed and implemented a phase gated Design Development/NPI process; Developed the Supplier Quality Assurance procedures and implemented a Global Audit Schedule; Developed policies for configuration management including training curriculum; Implemented MTBF and production quality metrics; Streamlined the Global supplier quality assurance program and established the global audit schedule.

Consultant -Quality System / Director of Quality System: (8/13 – 2014)

Development and deployment of Global Quality System across 6 sites.

Biolase Inc. 11/12 – 7/13

Director of QA – Responsible for all Quality Assurance and Compliance activities

Identified and filled all quality systems gaps in readiness for the annual ISO audit and obtained the continued certification with no major findings. Identified all gaps and initiated /implemented the required corrective actions in readiness for the FDA audit. FDA audit was conducted and completed with no 483s the week after I left the company.

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 0.7% (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, and 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. Clients include 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.

Key accomplishments are as follows- Implemented AS/ISO Quality Management System and obtained certification in 18 months, Obtained Quality System approval from AIRBUS and Boeing based on Aerospace Quality Standards (AS 9100) and obtained product offerability ;Established a team-based systematic corrective and preventive action system that turned around the poor product performance in the field and the customer perception; 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 ; Implemented paperless WEB based document control, Corrective/Preventive Action and training systems.

EDUCATION / CERTIFICATION

Bachelor of Science Electrical Engineering (Major: Electronics and Telecommunications)

Master of Science in Electrical Engineering (Major: Electronics and Communications) (Completed the coursework Requirements)

CTQM – Professional Certificate in Total Quality Management

Certification in Six Sigma (AlliedSignal Black Belt)

Certification in ISO13485 /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 Signal

Development of semi automated risk release control

Total Quality Award / Allied Signal

Cycle time reduction and productivity TB-23 Sonar Program

Total Quality Award / Allied Signal

Cycle time reduction and productivity SQR-19 Sonar Program

OTHER

Previous Federal Security Clearance



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