GIANG NGUYEN
San Jose,CA
Summary
Dynamic professional with extensive hands-on experience in the medical device industry, specializing in Class II, III, and in-vitro medical devices. Proficient in navigating regulatory frameworks, including 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and MDSAP, while successfully leading teams to achieve MDSAP and ISO 13485:2016 certification. Demonstrated expertise in product approval processes for therapeutic Class IIa devices and a proven track record of conducting regulatory audits with the FDA and other notified bodies. Strong background in medical device design controls, sterilization processes, biocompatibility testing, and lean manufacturing principles, ensuring high-quality standards and cost-effective solutions throughout the product lifecycle.
Overview
34
34
years of professional experience
1
1
Certification
Work History
Sr. Director, QA
Averto Medical, Inc.
Fremont, CA
08.2024 - 02.2026
- Management representative responsible for development and implementation of quality management system with scope including ISO 13485, EU MDR, and MDSAP (USA, Australia, Canada, and Japan) with audit readiness in 4 months and certification.
- Support engineering design and development of the Averto’s medical device, including coordinating the DHF, driving risk management process, validation of e-beam sterilization, and packaging validation (protocol development, testing, and report).
- Lead supplier quality management, including evaluation, auditing, and monitoring of suppliers performance.
- Lead quality audits, including the California State FDB and auditing organization, GMED.
- Support the filing of the application for an IDE clinical study in the U.S and OUS clinical studies.
Sr. Director, QA
Perosphere Technologies, Inc.
Danbury, Ct
02.2022 - 08.2024
- Directed the development of Perosphere's quality management system, ensuring readiness for MDSAP certification as management representative.
- Oversaw supplier quality performance management, focusing on contract manufacturers in San Jose.
- Facilitated comprehensive training programs to enhance understanding of QMS, design control, and risk management processes.
- Assisted in compiling and organizing necessary materials for 510(k) filing to ensure timely submission.
- Developed software development life cycle processes to ensure compliance with IEC 62304 and enhance cybersecurity measures.
Director of QA/RA
Atonarp Inc.
Pleasanton, CA
02.2022 - 02.2023
- Developed and executed Quality Management System to ensure adherence to ISO 13485:2016 regulations.
- Facilitated collaboration among research team members on the design and development of in vitro diagnostics for dialysis, focusing on MRD, PRD, and SRS specifications.
- Establishment of regulatory roadmap in support of Atonarp’s business strategy for US and Japan
- Executed installation and validation of EQMS utilizing Arena PLM software.
- Led and directed software development team to ensure compliance with IEC 62304 and other relevant standards.
Sr. Quality Assurance Manager
Pulse Biosciences, Inc.
Hayward, CA
10.2018 - 02.2022
- Management representative and member of quality management team
- Responsible for the effective implementation of QMS
- Achieved ISO 13485:2016 & MDSAP certification
- Initiated device conformity assessment via MDD with notified body
- Provided quality engineering support and resources to product development and manufacturing
- Responsible for the management of the supplier quality program, including supplier audits, evaluation and monitoring of supplier performance
- Completion of UDI and eMDR process development
Director of RA/QA
Channel Investments, LLC. (dba Tria Beauty)
Newark, CA
07.2017 - 10.2018
- Management representative and member of top management team
- Responsible for the QMS and all regulatory affairs
- Providing leadership and regulatory pathways into different international markets
- Lead MDSAP and ISO 13485:2016 certification effort with MDSAP stage I & II audit completion in July with TUV NORD
- Obtained CE mark for the Acne Clearing Blue Light, Gen2 with notified body, TUV Rheinland
- Successfully registered Acne Clearing device with ARTG in conjunction with Emergo Australia, as the sponsor
- Host state FDB, MDSAP and ISO 13485:2016 certification audits by California Department of Public Health (Food and Drug Branch), and notified body
- Lead supplier management and quality oversight of CMO producing finished medical devices overseas.
Sr. Quality Assurance Manager
Ivy Sports Medicine/Stryker Corporation
Redwood City, CA
02.2016 - 07.2017
- QA lead in integration of quality management system into Stryker’s system
- Led and hosted FDA site inspection and ISO 13485 surveillance audit with no audit finding
- Primarily responsible for the management of the quality system to ensure continuing compliance with QSR, ISO 13485, MDD, and management representative
- Effectively manage the contract manufacturer to ensure new AIR (All-Inside Repair) device project meets Ivy’s business goals through fostering positive collaboration and constant communication
- Manage supplier quality to ensure raw materials and purchased products consistently meet requirements
- Lead implementation of UDI for class II devices
- Provide regulatory change guidance and effect analysis to Ivy leadership team to ensure new product launch aligns with overall business strategic initiatives.
Principal Quality Engineer/Management Representative
Tria Beauty Inc.
Dublin, CA
11.2013 - 02.2016
- Establishing quality objectives with alignment to corporate strategy and goals, and managing compliance risks with regular communication to executive management
- Management responsibility for CAPA, RMA, and complaint handling process with team of 3 specialists
- Successfully leading management review, recertification audit with notified body
- Support contract manufacturing through supplier audits and process improvements.
- Lead audits, including internal, supplier, and certification body
- Successful establishment and coordination with EU authorized representative, MDSS (Medical Device Safety Service) in EU
- Develop Technical File for new medical devices in conformance with medical device directives
- Support device safety testing (IEC 60601 series, IEC 60825) and software validation (IEC 62304) for devices during development, including risk management file
- Support the implementation and validation of Customer Relationship Management (CRM) for Complaint Handling and RMA processes
- Responsible for the filing of Laser Product Report for new product and Annual Laser Report with CDRH.
- Lead development of device and product risk management (ISO 14971) assessment, master verification and validation plans, process validation protocols and reports.
Contract Manufacturer Quality Management
Robert Bosch, Healthcare Telemedicine
Palo Alto, CA
08.2009 - 11.2013
- Lead management of contract manufacturers (China and US) for the manufacturing of HCTM devices
- Responsible for supplier base quality management, including audit & qualification, quality performance, QBR, scorecard, Supplier Quality agreement
- Established quality plans for individual products per CM and quality control plans at the CM.
- Driving continual cost reduction through process efficiency improvement, materials selection, inventory management
- Responsible for quality processes including CAPA, Internal Audit, Non-conforming Materials
- Support of development of next generation Health Buddy device throughout the design phases
- Lead device risk management process: conducting hazard analysis, risk management plan, report, FMEA, and maintain risk management files
- Responsible for training team on process validation at OEM for blood pressure monitor and Bosch Ovar, Portugal.
Sr. Quality Engineer
Access Closure, Inc.
Mountain View, CA
02.2009 - 08.2009
- Managed quality processes such as CAPA, internal audit, Nonconforming materials, risk management, design verification and validation, incoming/in-process/final inspection, LAL testing for final product release.
- Supported customer complaint investigation of returned devices and MDR process
- Supported the 5F Mynx Vascular Closure Device development and manufacturing in design controls and process controls for device launch
- For 5F Mynx project, responsibilities include developing Validation Master Plan, biocompatibility testing of new materials, accelerated aging, process OQ and PQ protocols, risk control processes (eg. Risk/Hazard analysis and FMEA)
- Support new R&D projects for the development of new more robust balloon using new materials and larger size closure devices.
- Responsible for quarterly E-beam sterilization method dose audit
- Responsible for the CER qualification, maintenance, and monitoring
Principal Quality Engineer
Solta Medical, Hayward, CA./Reliant Technologies, Inc.
Mountain View, CA
07.2006 - 02.2009
- Managed supplier quality audits and improvement. Led 6-Sigma team on Supplier Certification program to improve supplier overall quality, Quarterly Quality Review of scorecard and metrics
- Managed and conducted process validations to ensure compliance with QSR requirements
- Supported compliance to quality system regulations with regards to customer complaints, internal audits, supplier approval, supplier audits, risk management and other quality processes
- Coordinated & managed the design control process activities with the R&D team for the design & development of Fraxel re:pair Laser System ensuring regulatory compliance with Quality System Regulations, ISO 13485, and Canadian CMDCAS and release for sale
- Developed design validation testing protocol/report for the Fraxel re:pair Laser System
- Coordinated with TUV in the conduct of electrical and laser safety testing per IEC 60601-1, 60601-1-2, IEC 60601-2-22, IEC 60825, and 60601-1-6.
- Produced reports and metrics for quarterly Management Review of Reliant quality system
- Supported effort on continuous product improvement with service, manufacturing, and R&D
- Led a small integration team for the company merger, relative to production move and process revalidation of key production processes in completing IQ, OQ, PQ.
Sr. Quality Engineer/ Management Representative
Xoft Inc.
Fremont, CA
10.2003 - 07.2006
- Administered Xoft Quality Management System, focusing on compliance with Quality System Regulation and ISO 13485 standards.
- Directed certification process for quality system to ISO 13485:2003 with TÜV Rheinland.
- Facilitated design control initiatives by mentoring engineering team on best practices and compliance standards.
- Oversaw document control systems to enhance incoming quality inspection processes. Led initiatives for corrective action plans to improve product quality. Directed internal quality audits and calibration efforts to ensure compliance with standards.
- Directed supplier qualification team in assessing new suppliers via comprehensive site audits.
- Formulated design verification and validation plans while providing leadership to ensure compliance with company design control requirements.
- Led quarterly quality management review meetings with executive management team.
- Executed sterilization validation and biocompatibility testing for silicone-based disposable devices.
- Developed system hazard analysis, Failure Mode and Effect Analysis for Xoft Axxent Electronic Brachytherapy System
- Collaborated with contract manufacturers to develop and enforce a comprehensive quality plan, ensuring robust process and quality controls.
- Led company training sessions on diverse quality system requirements and policies.
Sr. Quality Engineer
Boston Scientific Corporation
Santa Clara, CA
05.2002 - 10.2003
- Conducted Controlled Environment Room qualification including IQ, OQ, PQ both at static and dynamic states of operations.
- Managed microbial monitoring of CER to ensure bioburden level is under control on devices
- Managed quarterly dose verification for Electron Beam and Gamma Irradiation processes for Boston FilterWire disposable device.
- Managed supplier base by evaluating supplier performance via site audits and process data.
- Conducted various equipment qualification including pouch sealer for packaging.
Sr. Quality Engineer
Lumenis Ltd. (Coherent Medical Group)
Santa Clara, CA
01.2001 - 05.2002
- Provided quality engineering support to aesthetics and surgical laser product lines
- Quality team representative for new product development with R&D.
- Let FMEA activities, establish device CE dossier
- Executed internal quality audits, reviewing and making improvements to quality system
- Developed supplier performance metrics for electronics commodities and custom parts
- Lead a team assessing Contract Manufacturer capability for outsourcing of PCBA, cable, and system integration
Sr. Quality Engineer
Sunrise Technologies International Inc
Fremont, CA
05.1999 - 12.2001
- Developed and implemented Quality System to ISO 9001:1994 and GMP compliance per QSR
- Integral team member during PMA manufacturing audit and close-out of 483s
- Set-up and managed supplier base quality performance
- Developed and implemented ESD control program, Inspection processes, SPC tracking of incoming inspection, in-process inspection, CAPA, Final Test
- Performed mechanical design verification and testing of various subassembly level of the Holmium laser system
- Participated in software validation of Hyperion LTK System
- Assisted in obtaining CE and ETL marks (EN 60601-1-2, IEC 60601-1, IEC 60601-2-22) via compliance testing at ITS and TUV.
Sr. Manufacturing Engineer
Sanmina Corporation
San Jose, CA
11.1995 - 05.1999
- Developed and implemented quality plan for new customer products, prototypes, and quick turns for PCBA, backplanes, and system assembly.
- Developed SMT process, mechanical assembly of Printed Circuit Board Assembly
- Developed manufacturing process and quality plan for Iris Medical, Nortel Networks and Cisco product lines
- Implemented ESD program for facility
- Critical Defect and Cost Reduction team member interfacing with customers
- Developed continuous quality improvement program with suppliers for sheetmetal, molded and machined products
- Worked directly with Cisco NPI engineers on introduction of 6500 product line on DFM/DFA
Manufacturing Engineer II
Solectron Corporation
Milpitas, CA
06.1992 - 11.1995
- Provided assembly and test labor estimates in support of RFQ/RFP process
- Assigned as the customer account focal point of contact for technical issues concerning PCBA & system manufacturing and test for IBM Kiosk and Hewlett-Packard printing mechanisms
- Calculated direct manpower loading capacity to support high volume manufacturing
- Developed and sustained manufacturing process and test documentation, tooling/fixture requirements
- Evaluated assembly and test labor content for manufacturing of new products, engineering changes, field upgrades, and capacity planning
- Conducted process improvement in assembly for improved productivity and cost reduction
Education
MBA -
University of Phoenix
Bachelor of Science - Mechanical Engineering
San Jose State University
Skills
- Collaborative leadership
- Culture transformation
- Team management
- Policy development
- Coaching and mentoring
- Vendor relationship management
Certification
- ISO 13485:2016 Lead Auditor, BSI
- EU MDR 2017/745 Training, BSI
- Purchasing Controls and Supply Chain Management for Medical Devices, AAMI
- Evolving Risk-Based Regulatory training by RAPS
Timeline
Sr. Director, QA
Averto Medical, Inc.
08.2024 - 02.2026
Sr. Director, QA
Perosphere Technologies, Inc.
02.2022 - 08.2024
Director of QA/RA
Atonarp Inc.
02.2022 - 02.2023
Sr. Quality Assurance Manager
Pulse Biosciences, Inc.
10.2018 - 02.2022
Director of RA/QA
Channel Investments, LLC. (dba Tria Beauty)
07.2017 - 10.2018
Sr. Quality Assurance Manager
Ivy Sports Medicine/Stryker Corporation
02.2016 - 07.2017
Principal Quality Engineer/Management Representative
Tria Beauty Inc.
11.2013 - 02.2016
Contract Manufacturer Quality Management
Robert Bosch, Healthcare Telemedicine
08.2009 - 11.2013
Sr. Quality Engineer
Access Closure, Inc.
02.2009 - 08.2009
Principal Quality Engineer
Solta Medical, Hayward, CA./Reliant Technologies, Inc.
07.2006 - 02.2009
Sr. Quality Engineer/ Management Representative
Xoft Inc.
10.2003 - 07.2006
Sr. Quality Engineer
Boston Scientific Corporation
05.2002 - 10.2003
Sr. Quality Engineer
Lumenis Ltd. (Coherent Medical Group)
01.2001 - 05.2002
Sr. Quality Engineer
Sunrise Technologies International Inc
05.1999 - 12.2001
Sr. Manufacturing Engineer
Sanmina Corporation
11.1995 - 05.1999
Manufacturing Engineer II
Solectron Corporation
06.1992 - 11.1995
Bachelor of Science - Mechanical Engineering
San Jose State University
MBA -
University of Phoenix