Robert Christopher Egan
Irvine,CA
Summary
Over 15 years of experience in the field of quality assurance working in various industries, Medical Device, Semiconductor, Photonics and Contract Manufacturing using the following systems, tools and methodologies. ISO-13485, ISO-1497, ISO 9001-2015, SPC, FMEA, DOE, DFM, QFD, PPAP, ASQ Z1.4, Z1,9, Squeglia Zero-Based AQL Sampling Plans.IPC-A-610, 600, IPC-7711, 7721, IPC/ WHMA-A-620. Extensive knowledge of PCB/PCBA manufacturing, testing and integration, optical design and coating, fiber optic cable assembly, machining processes for high precision machined and Sheetmetal components. Technical lead for implementation and transfer of PCBA for power supplies and laser products/components for RoHS and WEEE directives throughout manufacturing and overseas supply chain. Solid knowledge in SPC implementation in manufacturing to determine process control and capability (Cp, Cpk).
High-energy, self-motivated, ability to work both independently and in a team environment. Strong analytical skills with high level of supplier interface with multiple suppliers in effort for continuous improvement, maintaining quality programs and standards. Successful product/program manager
Overview
23
23
years of professional experience
1
1
Certification
Work History
PRINCIPAL ENGINEER, SUPPLIER IMPROVEMENT/DEVELOPMENT
MKS INSTRUMENTS.INC
12.2015 - Current
- Partner with Global Supply Chain - Category Management, Procurement, Design Engineering, Manufacturing Engineering, Manufacturing/ Operations, Quality, and others to execute supplier quality management and development activities within the supply base
- Responsible to work with key MKS suppliers to grow their capability and control to drive robust & consistent processes
- Execute supplier quality activities of purchased products for NPI and Volume Suppliers (Supplier approval, Product qualification/FAl, Nonconformance management, Supplier Corrective Actions, supplier surveillance activities, etc.)
- Function as liaison and technical team leader between Engineering and suppliers to ensure conformance of purchased products to MKS specifications
- Lead supplier development activities to increase suppliers' capabilities to manufacture product consistently
- Mentor suppliers in lean manufacturing principles and activities
- Evaluated vendor proposals for equipment procurement, selecting optimal options based on cost-effectiveness and performance criteria.
SENIOR QUALITY ENGINEER
UCT
03.2012 - 01.2015
- Managed medical customers as the CQE (Customer Quality Engineer) Ensuring high level of compliance to Customer specification, FDA QSR/cGMPs and ISO 13485 in all assigned areas are met
- Resolve all customer complaints, driving timely disposition and closure
- Project Manager / Team Leader for the implementation of ISO-13485:2003 QMS for corporate headquarters, registration certificate granted
- Jan 14, 2014
- Trained audit team to ISO-13485 and 21CFR-Part 820 regulations
- Established internal audit plan/schedule and conducted internal audits
- Audit team leader for all medical suppliers, and subcontractors
- Lead activities related to customer product integration and any other areas such as Risk Management, Process Validation, Test Method Validations, Part Qualification, IQ/OQ/PQ protocols, and reports
- Technical advisor in the evaluation and qualification of new supplier materials
- Participates on definition of material specifications with R&D, Engineering, Technical Operations, Purchasing and Suppliers
- Review made to print items and recommend critical inspection requirements versus customer documentation, determine critical characteristics and established IQC inspection points based on drawing specification and assembly OMS
- Create inspection plans identifying, inspection tools, inspection methodology and AQL sample plan, trained IQC personal on GD&T principles and measuring techniques
- Guide IQC on resolving daily incoming, WIP, and final inspection issues
- Developed and managed all medical IQC functions, including Gage R&R, Cp/Cpk analysis, inspection records, supplier FAIR and thirdparty inspection lab activities
- Established DHR requirement and developed process
- Managed DHR team and performed final DHR package review prior to product shipment
- Work with Purchasing to report supplier performance, support an escalation path in case of ongoing supplier quality issues, ongoing bad supplier rating and uncooperative suppliers
- Work closely with internal departments (Operations, NPI
- Supplier Management to resolve customer complaints, in-house and supplier quality problems using established problem-solving methodologies (8D methodology, Root Cause Analysis, Mistake-proofing, etc.)
- Review/approve product and/or process change control documentation and specifications
- Periodically Review SOP/WI’s and update accordingly
- Generate, analyze, maintain, and report customer quality metrics to VP of Quality
QA/CQC STAFF ENGINEER
COHERENT INC
09.2008 - 11.2011
- Responsible for QE/SQE support of four BU, Semiconductor, DPSS, HOPS, DDF of laser components such as machined components, ceramic sub mounts, coatings, PCB/PCBA and domestic/overseas contract manufacturing
- Development of quality plans internal and external
- Implement and drive established methods for new and existing products for mechanical inspection, final product acceptance, HALT, HASS and PCBA inspection and test requirements
- Managed CAPA database, investigated and resolved problems with manufacturing of raw material, components, and product assemblies
- Analyzed field failure reports of customer return products, identified failure modes, root cause, and presented results along with corrective actions to management in detailed failure analysis reports
- Created technologically informative presentations, documents, manuals, and procedures, and present these to relevant groups within Coherent
- Represented the quality department in a variety of quality improvement areas such as (CCB) Change Control Board and (MRB) Material Review Board
- Investigated NCR’s, analyzed data and reported monthly all site quality related statistics and metrics
- Provide coordination and technical support to management and other personnel
- Performed internal and external quality audits of QMS to ISO 9001-2008, ISO 13485 as required
- Implemented Lean 6 Sigma techniques and projects within each business unit for continual improvement, cost reduction and improved overall product quality and reliability
SENIOR QUALITY ENGINEER
SANTUR CORP
04.2007 - 08.2008
- Responsibilities as the SQE included supplier site audits, overseas product transfer, qualification, development, performance quality of optoelectronic / laser components such as machined components, packages, sub mounts, coatings, PCB/PCBA and contract manufacturing
- Provide technical direction and assistance to design engineering, procurement, and manufacturing, receiving inspection and supplier activities
- Consult with engineering personnel to establish material purchasing specification, inspection plans, standard operation procedures (SOP) and performance criteria for manufacturing and testing
- Monitor and trend overseas production activities, identify areas of concern and utilize a scientific approach to implement corrective actions to achieve company yield and shipment requirements, as well as cost reduction goals
- Review production processes with Engineering to resolve manufacturing efficiency and DFM issues with Engineering
- Conduct /participate in Material Review Board (MRB), Change Control Board (CCB) and Corrective Action Requests (CAR) as required
SENIOR SQE/QE
PHOTON DYNAMICS
02.2006 - 04.2007
- Responsible for supplier development, performance and quality of custom optics, advanced camera vios, PCB/PCBA, mechanical electrical sub-assemblies, solid-state lasers, and contract manufacturing
- Lead and coordinate supplier risk analysis and technical assessment audits and/or participate with Purchasing and Engineering during the supplier identification, development, and qualification process
- Development and execution of process characterization and validation on supplier processes using quality tools such as statistical analysis, process qualification plan (PQP) and reliability testing
- Established first article testing requirements for new materials and components, supplier design reviews for NPI products including coordination of critical measurements, gauging systems, evaluation of process stability and process capability
- Non-conforming material review and disposition, supplier auditing and troubleshooting / root cause analysis, continual improvements to process control, test methods, inspection criteria and related documentation used to evaluate product functionality and quality
- Assisted in the development and review of product specifications and test requirements including the development of critical characteristics and tolerances for manufacturing, process control inspection and quality acceptance
- Independently coordinated and performed product failure analysis activities to determine root cause of failures and determine corrective action recovery plan with production and suppliers
SENIOR PROCUREMENT ENGINEER
JDS UNIPHASE
09.2002 - 10.2005
- Responsible for custom display products, glass, custom optics, machined components, nickel / gold plating, hermetically sealed packages, chemical etching, and optical coating with a net annual revenue of $50,000,000
- Introduced lean sigma techniques for capacity planning, reduce machine / process cycle and takt time
- Improve lead-times and on time delivery consistent with business objectives of 98%
- Identified opportunities and implement cost improvement plans at existing suppliers to continuously reduce cost to meet business objectives of 6 % per fiscal quarter
- Developed new supply chains in Southeast Asia, China
- Japan and Europe in effort to reduce overall product cost by 15-20 % to meet the company and customers pricing expectations
- Developed supplier qualification and control plans requiring DMAIC principles, process control, SPC, statistical sampling, traceability and critical to quality (CTQ) requirements for new and existing products
- Performed measurement system analysis studies (Gage R&R) on equipment used throughout various processes to ensure product specification can be measured consistently and accurately
- Performed DOE, FMEA and advanced statistical analysis to improve overall process yields, reduce material cost and incoming inspection, result net savings 15%
- Performed onsite supplier quality surveys and process audits in compliance with ISO 9001-2000
- Assess potential supplier technology expertise and perform risk analysis to insure TQCRD business objectives are met
Education
AA - Electrical Engineering Technology
HEALD INSTITUTE OF TECHNOLOGY
HAYWARD, CAIndustrial Technology, Concentration: Quality Management
SAN JOSE STATE UNIVERSITY
SAN JOSE, CAAA/Certificate - Industrial Tool Technology
CHABOT COLLEGE
HAYWARD, CASkills
- MS Word
- Excel
- Presentation
- Visio
- SQC Pack
- Minitab
- JMP
- AutoCAD
- Oracle
- SAP
- Agil
- Project team leadership
- Document review
- Project management
- Data review
- Cross-functional collaboration
- Continuous deployment
- Excellent communication
- Document review
- Project management
- Data review
- Cross-functional collaboration
- Continuous deployment
- Excellent communication
Certification
Lean Sigma Green Belt, Geometric Dimensioning and Tolerance ASME 14.5 1994, ISO1101, ISO13485, FDA/21CFR-Part 820, Quality System Regulation / Medical Devices RABQSA Lead Auditor Training, BSI, IPC-A-610/IPC/WHMA-A-620 Certified Trainer (CIT)
ASQ (American Society for Quality Control). Active member.
Timeline
PRINCIPAL ENGINEER, SUPPLIER IMPROVEMENT/DEVELOPMENT
MKS INSTRUMENTS.INC
12.2015 - Current
SENIOR QUALITY ENGINEER
UCT
03.2012 - 01.2015
QA/CQC STAFF ENGINEER
COHERENT INC
09.2008 - 11.2011
SENIOR QUALITY ENGINEER
SANTUR CORP
04.2007 - 08.2008
SENIOR SQE/QE
PHOTON DYNAMICS
02.2006 - 04.2007
SENIOR PROCUREMENT ENGINEER
JDS UNIPHASE
09.2002 - 10.2005
AA - Electrical Engineering Technology
HEALD INSTITUTE OF TECHNOLOGY
Industrial Technology, Concentration: Quality Management
SAN JOSE STATE UNIVERSITY
AA/Certificate - Industrial Tool Technology
CHABOT COLLEGE
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