WATTANA VONGSAVANH
Pinellas Park
Summary
Dynamic Lead Quality Engineer with extensive experience at Halkey Roberts, driving quality improvements and leading cross-functional teams. Proficient in FMEA and Six Sigma methodologies, I excel in problem-solving and communication, ensuring compliance with ISO 13485 standards while enhancing product quality and supplier performance. Committed to continuous professional development and excellence.
Overview
36
36
years of professional experience
Work History
Lead Quality Engineer
Halkey Roberts
Saint Petersburg
02.2021 - Current
- Company Overview: ISO 13485:2016
- Manage projects for new technology introduction (machining to metal injection molding) from introduction to launch
- A representative and point of contact that takes care of the customer’s needs
- Responsible for continuous product and process quality improvements
- Resolves customer issues appropriately and in a timely manner
- Communicate with customers, members of Field Service, and the Sales organization to collaborate and ensure issues are resolved quickly and effectively
- Develop quality standards in accordance with company and customer requirements
- Accountable for supporting new product development and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices
- Handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements
- Responsible for creating and maintaining product and process risk management files to meet FDA and ISO standards
- Leads device material qualification activities and product transfer activities to current and new suppliers
- Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product
- Provide Quality oversight and approval of qualification/validation/design controls activities
- Liaison with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
- Leads root cause investigations and coordinates timely action implementation with the CAPA process
- Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
- Evaluates product changes and directs appropriate disposition of product through the company’s change control system
- Mentor and ensure continued technical and professional growth of the R&D, and Quality Engineering team members and encourage efforts towards excellence and knowledge sharing
- Utilize strong, professional communication (oral and written), organizational, and leadership skill
- Ensure new product introductions and change controls are effectively managed in accordance with the requirements of ISO 13485 and 21 CFR Part 820
- Ensure the necessary testing, evaluation, and control of equipment measures are in place to monitor and support product quality in accordance with the requirements of ISO 13485 and 21 CFR Part 820
- Drive suppliers to continually improve their business and manufacturing process performance to meet the requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation
- Develop strategies for suppliers and influence key stakeholders to utilize and maximize the use of preferred suppliers
- Manages all activities related to supplier quality in a variety of commodity areas including Build to Print, Contract Manufacturing, Mechanical, OEM, Consumables, and Electro-Mechanical assemblies
- Lead supplier qualification, Quality and process audits, develops gap analysis plans, manages supplier improvement plans, and monitors ongoing progress
- Evaluates work methods, procedures and policies. Tracks progress of qualification status, reviews reliability test results, determines disposition of non-compliant products, reviews and releases qualification packs
- Utilizes drawings, specifications, industry standards, and sketches, adapting inspection, qualification plans and procedures when necessary. Read and interpret technical drawings and specification requirements
- Reduces qualification cycle time and cost while still meeting quality performance requirements
- ISO 13485:2016
Senior R&D Product Line Engineer / System Engineer
SMITHS MEDICAL
Southington
03.2015 - 12.2020
- Company Overview: ISO 13485:2016
- Design Control governed environment, knowledgeable of device Design History File structure, Risk Management documentation and Design Verification and Validation
- Key member of product development teams representing as the project technical lead, the Quality and validation for the Invasive Blood Pressure Monitoring Closed Blood Sampling System
- Worked closely with sales, and marketing in product concept development, which involved capture and translation of Voice of the Customer input includes working with clinicians and doctors
- Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines
- Create & maintain Product Definition document to clearly articulate the scope of project, concept description, market opportunities, competitive landscape, use cases, and technical requirement specification
- Create a cadence in the meeting structure to ensure continuous progress on the roadmap & get stakeholder alignment
- Lead design validation plan
- Create & Maintain top level BOM & DHF
- Lead standards compliance plan
- Lead design review meetings
- Create, manage, & trace product-level specifications (e.g. Standards Requirement Specification, Technical Requirement Specification, Labeling, device characterization) including scope changes, updates, trade-offs
- Support, in collaboration with Sustaining Engineering, on design changes, VIPs, VE (as Product Line Engineer & System Engineer)
- Responsible for Quality deliverables such as Risk Management Report, AFMEA, DFMEA and PFMEA
- Write and execute Validation Plans (CQ, IQ, OQ, and PQ) and statistical analysis
- Develop / update specifications & documents based upon sustaining needs
- Lead validation of changes that may impact customer perception or use
- Manage technical interactions and timelines with external suppliers; provide technical information and expertise as well as technical issues
- Mentor interns and lab technicians
- Conduct Internal Audits
- ISO 13485:2016
QUALITY MANAGER
COMPONENT ENGINEERS, INC.
Wallingford
07.2012 - 03.2015
- Company Overview: ISO 13485:2016
- Work in a high-speed metal stamping process, CNC process, and automated assembly processes
- Supervised technical staff in carrying out tests and checks
- Effectively interact with Production and Development teams to maintain product supply and help introduce new products
- Defining quality procedures in conjunction with operating staff
- Bringing together staff of different disciplines and driving the group to plan, formulate and agree comprehensive quality procedures
- Manage and maintain the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods
- Manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC
- Setting QA compliance objectives and ensuring that targets are achieved
- Assessing the product specifications of the company and its suppliers and comparing with customer requirements
- Liaising with customers’ auditors and ensuring the execution of corrective action and compliance with customers’ specifications
- Working with purchasing staff to establish quality requirements for external suppliers
- Conduct Internal Audits
- ISO 13485:2016
LEAD QUALITY ENGINEER
SPINE WAVE (Spine Implants)
Shelton
02.2011 - 07.2012
- Company Overview: ISO 13485:2016
- Design Control governed environment. Knowledgeable of device Design History File structure, Risk Management documentation and Test Method Validation
- Key leader for quality system improvement
- Redefine quality acceptance level and plans to improve quality for a growing transitioning company
- Work closely with VP of Quality, VP of R&D and VP of Manufacturing to capture internal Voice of Customer and plan for quality system improvement
- Lead Process/Design Risk Analysis
- Lead multiple product Design Control activities for new product development efforts
- Provide leadership in understanding of the quality regulations to other disciplines
- Support Process/Design Validation/Verification activities
- Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
- Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing
- Responsible for improving Risk Management system / procedures
- Implemented system and procedures such as QFD (VOC), CTQ and Design Verification (FAI) and developing plans for a Supplier Quality Manual
- Trained all cross-functional team members on Risk Management tools (Application/Design/Process FMEA)
- Driver for Risk Management meetings
- Conduct supplier audits / Supplier development
- Develop quality assurance specifications / quality plan, test method and procedures, sampling plans, control plans, detailed inspection instructions and conducted training for inspection and manufacturing personal
- Quality Planning and Quality System improvement (Design for Six Sigma)
- Supervising technical staff in carrying out tests and checks
- ISO 13485:2016
SR. DESIGN QUALITY ENGINEER
MEDTRONIC (formally COVIDIEN - TYCO Healthcare)
North Haven
06.2005 - 02.2011
- Company Overview: ISO 13485:2016
- Design Control governed environment. Knowledgeable of device Design History File structure, Risk Management documentation and Test Method Validation
- Key member of product development teams representing Quality for the Visiport endoscopic surgery product
- Worked closely with engineering, manufacturing, sales, and marketing in product concept development which involved capture and translation of Voice of the Customer input, including work with surgeons and observation of surgeries
- Major role in product qualification developing quality requirements, developing suppliers and tooling, and qualifying the assembly process
- Support product launch through critical field-testing ensuring that products met design requirements
- Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment
- Collaborated with sale representatives to evaluate Clinical Field Test Units and observe operating room procedures
- Acquired and translated the Voice of Customer data into product specifications and facilitated the Quality Function Deployment process
- Continually seeks to drive improvements in product and process quality
- Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSC’s Product Development Process and Design Control requirements
- Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines
- Identifies and resolves complex exceptions to work assignments
- Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings
- Build Quality into all aspects of work by maintaining compliance to all quality requirements
- Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group
- Providing independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met
- Providing analytics to the Business on the efficacy and efficiency of the design and product realization processes
- Performing independent technical assessment on product quality performance and post‐market product quality analysis
- Leading quality related problem solving and root cause analysis during design and manufacturing stages
- Acting as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
- Responsible for Quality deliverables such as Risk Management Report, AFMEA, DFMEA and PFMEA
- Write and execute Validation Plans (CQ, IQ, OQ, and PQ) and statistical analysis
- Perform process qualification and maintain component status report
- Process Improvement - Maintain a low labor and material variance by utilizing Lean tools in the assembly processes to improve the instruments quality level
- Mistake Proofing / Poka Yoke assembly cell
- Utilizing the 8D problem solving process, drive problem resolution process at the supplier and manufacturing floor
- Made plans and strategies for improving the quality of product
- Develop statistical plan
- Attend Quality meetings at the supplier’s
- Improve quality level by reducing part flash that exceeds print specification at the supplier and avoided loss of production situation
- Improve quality level of Critical to Quality (CTQ) component by implementing LEAN practices, improving processes and quality system
- Improve quality level of CTQ feature on a component with .002 radius by designing and implemented a capable measurement system at the supplier
- Launched projects such as: V2 Fixation, Handswitch Atlas, Endo Clip III
- ISO 13485:2016
SENIOR MANUFACTURING / SENIOR QUALITY ENGINEER
VERTEBRON INC.
Stratford
06.2004 - 06.2005
- Company Overview: ISO 9001/2000
- Facilitate the Design FMEA and Process FMEA
- Design and qualify manufacturing and inspection fixturing / gauges using Autocad
- Execute First Article Inspection and process data review
- Produce detailed inspection and assembly instructions
- Made plans and strategies for improving the quality of product
- Maintain records of all test qualifications
- Conduct supplier audits / Supplier development
- Evaluate the initial samples and/or engineering change requests looking for product specification compliance, assuring the planning timelines correspond to the pre-series production vehicles, start of production and serial projects of new products
- Collaborate with suppliers in the process establishment and development of standard operating procedures
- Audit the product at the supplier to ensure that it is specification compliant and the manufacturing process and quality can be granted
- Develop the quality inspection method at the supplier
- Recommend technical product improvements evaluating risks and potential chances to avoid quality manufacturing issues, by comparing similar parts assembly line and field development
- Developing, proposing, coordinating and representing concepts for quality-assuring activity/improvement programs with/at suppliers and pursuing the implementation of executed measures
- Maintain Supplier Performance Storyboard and champion Supplier Performance review for underperforming suppliers
- Provide leadership in implementing Supplier Quality improvement and defect reduction plans
- Drive Quarterly goals to meet objectives. Create & Maintain Performance KPI’s
- Includes supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence
- Own and Lead monthly Supplier Performance Reviews on Top poor performing Suppliers with monitoring of corrective action plans
- Develop and maintain an open issue list along with a timing plan and report any concerns or issues to the core team
- Develop and obtain Supplier approved boundary/PPAP samples and maintenance of the boundary samples throughout the production cycle
- ISO 9001/2000
Sr. MANUFACTURING / QUALITY ENGINEER
LACEY MANUFACTURING INC.
Bridgeport
02.1990 - 06.2004
- Company Overview: ISO 9001/2000
- Work in a high-speed metal stamping process, molding process, CNC process, Four Slides assembly process and automated design assembly processes
- Support new product program and act as liaison for new product introduction into manufacturing
- Ensure that manufacturing processes and procedures comply with FDA, OSHA, ISO, corporate and divisional regulations, policies, and procedures (i.e. process qualification/validation, operation procedures, accurate standards, documentation, etc.)
- Identify and resolve repetitive and major production issues that are affecting department performance especially when resolutions of such issues require technical solutions
- Develop manufacturing process procedures and work instructions
- Responsible for tool manufacturing and liaising with internal and external tooling supplier
- Perform process capability assessment on new tooling and processes
- Design challenge and verification of production specifications by developing test procedures, conduct test and data analysis
- Responsible for qa/qc new product development in a medical product assembly environment
- Perform Risk Analysis DFMEA and PFMEA
- Actively promote 'hands on' team approach to the CAPA process across all departments
- Hands on mentor of the CAPA team Root Cause investigations and use of typical CAPA investigation tools
- Evaluate corrective and preventive action responses and assessed findings for adequacy, including root cause and timeliness and elevated issues to management
- Develop quality assurance specifications, test method and procedures, sampling plans, control plans, detailed inspection instructions and conducted training for inspection and manufacturing personal
- Design / qualify manufacturing assembly and inspection fixturing/gauges using AutoCAD
- Manage the Gage Calibration Department
- Verify gauges and write gauge calibration procedure
- Work directly with suppliers and customers in root cause failure analysis, problem solving and corrective actions
- Implement the Operator Inspection Program as a LEAN project
- Customer contact for Quality issues
- Deals directly with tooling vendors
- Work with the personal on the manufacturing floor and assembly line
- ISO 9001/2000
Education
Lean Manufacturing -
Covidien
01.2010
DFSS Green Belt -
Covidien
01.2007
Quality Engineering -
Naugatuck Valley Community College
01.1996
Tool & Die Design -
Porter and Chester Institute
Stratford01.1992
Mechanical Engineer -
University of Bridgeport
01.1990
Skills
- Proficient with Microsoft Office, Minitab, Adobe AutoCAD, LightRoom and PhotoShop
- Knowledgeable of and trained in, DOE, FMEA, GD&T, Control Plans, First Article Inspection and PPAP Submission, SPC, 8D Corrective Action, Six Sigma, Lean Manufacturing
- I have attended work-related continuing education courses and seminars throughout my career
Timeline
Lead Quality Engineer
Halkey Roberts
02.2021 - Current
Senior R&D Product Line Engineer / System Engineer
SMITHS MEDICAL
03.2015 - 12.2020
QUALITY MANAGER
COMPONENT ENGINEERS, INC.
07.2012 - 03.2015
LEAD QUALITY ENGINEER
SPINE WAVE (Spine Implants)
02.2011 - 07.2012
SR. DESIGN QUALITY ENGINEER
MEDTRONIC (formally COVIDIEN - TYCO Healthcare)
06.2005 - 02.2011
SENIOR MANUFACTURING / SENIOR QUALITY ENGINEER
VERTEBRON INC.
06.2004 - 06.2005
Sr. MANUFACTURING / QUALITY ENGINEER
LACEY MANUFACTURING INC.
02.1990 - 06.2004
Lean Manufacturing -
Covidien
DFSS Green Belt -
Covidien
Quality Engineering -
Naugatuck Valley Community College
Tool & Die Design -
Porter and Chester Institute
Mechanical Engineer -
University of Bridgeport