Aaron Van Email & Phone Number

Dublin, CA, US

Pittsburgh, Pennsylvania, United States

• Responsible for the structured analysis of product safety/compliance incidents in the market (including initiating follow-up) and ensuring remediation.
• Ensure BG/local commitment to product safety/compliance and sign off declarations on product safety/compliance and compliance on behalf of incidents BG/site management
• Lead all product safety/compliance-related activities in the SVAL/BG/Site to ensure that regulations and policies are fully and timely available and interpreted, products comply with all regulatory requirements, and.
• Perform the incident handling process, including review and decision-making on product safety/compliance-related escalations.
• Ensure proper root cause analysis in case of product safety/compliance noncompliance according to regulations and the 8D methodology.
• Support and consult proper reflection of all relevant regulatory requirements in all projects, OEM ODM products, including lifecycle management, and verify and validate designs regarding these requirements

California, United States

Santa Clara, California, United States

• Develops and implements programs and processes to ensure that company products are safe, legal, and meet or exceed customer expectations for compliance with national/regional/global regulations
• Represents quality/regulatory on new product introduction and product improvement projects
• Ensures risk management activities are conducted throughout the product lifecycle.
• Coordinates and follow-ups on quality audit activities and observations with cross-functional internal and external stakeholders (represents the company in external and internal audits, as needed.)
• Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance
• Proactively manages the changing regulatory environment for company products, prevents trade barriers, eliminates duplication of effort, and identifies and mitigates areas of risk

Irvine, California, United States

• Account and response for maintaining quality and control of manufacturing processes and post-market performance of medical devices
• Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and.
• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor the effectiveness
• Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

San Francisco, California, United States

• Self-Employee/Construction Project Manager for Home Improvement Project
• Manage Construction Projects to meet budget constraints with clients
• Review the design layout & search for quality materials with sustainable choice products (suppliers to the clients)
• Lead cross-functional teams, facilitate and resolve obstacles for the development teams, and use encouragement, influence & escalation to keep the team on track and raise issues in a timely fashion
• Use MS Project to track the project timeline, purchase order, and state prioritized of the tasks that should be performed during the construction process first for the project
• Coordinate and collaborate with suppliers/clients to inform the quality and quantity of purchase orders, inspect the product to ensure the quality meets the client's expectation with the highest quality of the purchase.

Berkeley CA

• Negotiated and requested suppliers/manufacturers to revise the purchase orders (PO), change orders (CO), and service level agreements (SLA) to save $65k capital budget for the first project
• Constructed successfully process improvements with FMEA and CAPA through project team
• Managed and coordinated well on Engineering change order (ECO), SOP (Standard Operating Procedure), and reliability analysis that cause of the system failures with the Kaizen method to meet company goal and mission
• Created, reconciled, and managed SAP, CRS, REEDS, and Deviation (DR) issues from the approval to final stage
• Supported statistical techniques, URS, CVR, SDS, Trade Metric, SPC for proceeding validations, studied temperature control of incubators and refrigerators by using heat transfer & thermodynamic to determine heat.
• Coordinated with vendors, Instrument Qualification & Software Validation team, IT team to ensure the entity software's are privileges and install properly to the manufacturing process and quality control (for.

Berkeley, California, United States

• Created Z1, Z2, Z3, and Z.T. in SAP for Maintenance Plan, worked with individual project managers, developed project plans, organized, and updated last lists by adding, modifying, reconciling tasks types
• Evaluated and ensured purchase orders (change orders), service level agreements, and amendment for the impacted project and to meet the project schedule-timeline
• Reviewed process IQOQPQ to meet manufacturer standards, compliances, quality assurance (Q.A.), quality control environment monitoring (QCEM), 21 CFR 11 ( 820 & 860), FDA, and ISO regulations
• Managed SAP for calibration such as forecast of PM notifications under maintenance schedule review report, changed PM order, and reconciled the pass due Cal (Overdue PM) to ensure production scheduling demands are met
• Overseed equipment PM and maintenance, assisted the deviation gaps with root cause analysis, prioritized project time management, and communicated & escalated process maintenance with vendors to perform PM qualifications
• Plan and schedule site services for PM+IQOQPQ equipment such as Agilent HPLC (L.C., G.C., I.C., CAD Detectors, Waters), Refractometer, Polarimeter, K.F., UV-Vis, Viscometer, Chloride Analyzers, TOCs

Pleasanton, California, United States

• Tested/improved/troubleshoot hardware and software to determine the configuration issues in test fixtures, prototypes for mechanical devices with electronic lab test equipment, validated IQ/OQ/PQ production protocols.
• Provided, Identified, and interacted with corrective actions relating to Design History Files for commercialized products
• Developed, evaluated, and executed test for the medical device's equipment, included measuring part qualification to ensure the exercise of Good Documentation Practices (GDP) and compliance
• Used engineering tools to implement and improve QSR, QMS, and evaluated non-conforming products to support the complaint issues for manufacturing
• Applied 5 strategies such as plan, define, develop, verify, and deploy in compliance to establish Design Control under the government regulation and engineering standard requirement as using the quality tools and.
• Supported customer complaint and the root cause of product failures per CAPA, then transfer an action to the investigation technical team/specialist to resolve the issue ASAP for this matter (HMII & Battery issues)

San Francisco Bay Area

• Performed and Negotiated project costs with specialized in residential, commercial, retail, and kitchen & bath design
• Managed projects (including Initial/concept/schematic diagram, design development, preparation of construction documents, cost control & budgeting, material selection, and coordinate with general contractors) and.

Marlborough, MA

• Performed polymer formulation, analyzed analytical test methods, and established production process for GC, LC, GPC, HPLC, IC, pH Meters, and TMAH titration to improve and execute bioresorbable drugs
• Evaluated, approved, and performed Raw Materials and Micro Final Products to ensure production and process controls in compliance such as production & process changes, environmental control, contamination control.
• Applied chemical reaction and thermodynamics to create Process Map, Flow Diagram, Fish Bone analysis, FMEAs, Cause and Effect Matrix to improve repeatability and reliability BDR TestSafety Member Council: EHS-Safety.

Boston, MA

• Performed a variety of clerical and technical duties under general supervision, responded all specimens for receiving verification, initial and centrifugated processes, and reported test results to senior Technologist
• Dealed with patient's samples in an appropriate and efficient manner, distributed to the appropriate area of the laboratory or other hospital departments as necessary according to procedure.

Methuen, MA

• Scaled-up purification for raw material/wet chemical for manufacturing processes
• Analyzed all applicable requirements, implemented documentation for Manufacturing Process Specifications, discussed the improvement processes with engineering group, and assisted and adhered Quality Assurance update.
• Applied all elementary concepts in chemical reaction, thermodynamics, transport phenomena to formulate, operate, improve, evaluate alternative batch processes and involved trouble-shooting problems to assistant process.

N. Billerica, MA

• Inspected with several pharmaceutical drugs such as Cardiolite, Neurolite, Thallium 201, I.V. Persantine, Miraluma, Quadramet (Sm153), Gallium citrate, and Xenon-133
• Monitored the final shipping products in hot and cold radioactive areas (included inventory report, monitored packages, and worked on a technelite Tc99m Generator)Specific Skills: Hazmat, Industrial Safety, Radiation.

Pmp, Project Management

Activities and Societies: VOLUNTEER AFFILIATIONS TOASTMASTERS INTERNATIONAL, DISTRICT 57 10/2020-CURRENT Area D26 Director 2023-2024.

Bachelor Of Fine Arts (B.F.A.), Interior Architecture And Design, 3.2

Activities and Societies: ASID and AIA Recognition Design Magazine for DIFFA Dining By Design 2007 Attended Lighting Lectures/Training.

Bachelor Of Science (B.S.), Chemical Engineering

Activities and Societies: ECHEM Minor: Chemistry, Computer Science, and Concentration in Paper for Chemical Engineering