Operations Manager Project Management

VU HOANG

San Jose, CA 408-***-**** ***.*****@*****.***

INTRODUCTION

Servant leader with a depth of experience driving results, improving efficiencies, and continually elevating processes in a fast-paced, highly regulated environment. Adept project manager who applies Lean manufacturing principles to scheduling and production. Committed to developing employees from recruiting to retention by establishing key metrics and providing individuals and teams with the skills needed to meet them. Passion for and focus on environmental health and safety (EHS) through ongoing documentation of best practices and employee training. Review all data to identify opportunities for advancement and mitigate potential challenges.

PROFESSIONAL EXPERIENCE

Operational Leadership 70+ Employees Supervision Training & Career Development Performance Metrics Customer Satisfaction Production Schedules SAP, Epicor, Jira, Maximo, Visio Personnel Management Service Optimization Laboratory Management Lean-6 Sigma Manufacturing Continuous Improvement Regulatory Compliance FDA, ISO 9001, 13485 In-Vitro Diagnostic & Med Device Manufacturing Strategies EMD Electronics – Merck KGaA, Santa Clara, CA – Site Operations Manager IV 08/2022 – Present Managed gas and chemical facility with a TEAM of 7 supervisors and 70+ employees providing 24/7 services to support wafer research business units, located on the Applied Materials site. Ensured safety first and quality compliance with OSHA and EHS. Managed site budget and cash flow, new gas line projects, facilities maintenance, Management Review, 8D meetings, logistics, and inventory control. Maintained strong cross-functional relationships across operations (EHS, facilities, engineering, sales). Brought a new management way (servant leadership) to inspire TEAM culture, morals, and work efficiency.

• Improved field safety and quality performance by concentrating on one task rather than multitasking.

• Boosted quality performance by focusing on rectifying specific departmental issues.

• Enhanced site safety after assigning 2 employees to each field project: one to read SOPs and one to perform tasks; jobs were halted when they lacked SOPs or safety protection. Implemented “STOP the JOB” slogan. Mass Precision, Fremont, CA – Quality Program Manager 05/2021 – 08/2022 Directed to develop the quality program with a goal of supporting NPI production, QA and QC in USA and Malaysia. Managed the program focused on developing the new supply vendor quality program, vendor audits, and review vendor process. Direct developed a program to improve teamwork efficiency, work cultural morals, and TEAM motivation through transparency communication from manager levels down.

• Coordinated and communicated decisions driven by CEO to manage the aspects of given project from start to finish.

• Acted as a key interface and coordination point contact with other departments to ensure outstanding driven to project execution, process and product quality, product deliverables, complaint issues, budgets, and schedules.

• Participated in the development Quality Improvement Action Plan, Annual Quality Plan, Quality Safety Standards review. Analyzed Supply Chain Management and produced new quality check solutions to Malaysia facility. Precision Swiss, Milpitas, CA – Senior Quality Manager 09/2020 – 05/2021 Led and managed QA/QC of CMM lab and maintained QMS and document control system. Monitored quality inspection, investigated CAPAs, NC products, root cause analysis (P-FMEA). Provided customer solutions, process validations (IQ, OQ, PQ), preventive maintenance, and equipment calibration. Also responsible for managing shipping, RMA status, and inventory control. Managed and reviewed the performances of 2 engineers, supervisor and 13 employees. Projects included Midlab - Vitrectomy Probe, Edwards Lifesciences - Adjustment knob for Heart Valve surgery, and Crance AERO.

• Conducted quality management reviews, raw material approval, and approved internal process and product audits.

• Tracked and interacted with suppliers and customers for quality issues, audits, recalls RMAs, and raw materials reviews.

• Handled all customer complaints and concerns regarding quality issues, NPIs, RMAs, and MRAs. Bravo Health, Santa Clara, CA – Business Operations Manager 02/2019 – 07/2020 Participated in set up the business operations from ground zero to growing, keeping business at highest profitable operations, developing distribution process of healthcare monitoring equipment (blood pressures, heart rate, glucose, oxygen level, radiation protection, x-ray accessories).

• Worked with Finance to develop Business Management structure to ensure a dynamic and efficient business operation focused on sales, projects, budget, and resources.

• Identified and maximized sales opportunities, increased customer retention rates, and monitored vendor’s distribution.

• Managed employee hiring processing and payroll, and resolution employee concerns related to the jobs. Vu Hoang ***.*****@*****.*** Page Two

Festo Corp, Livermore, CA – Production Project Manager 04/2014 – 02/2019 Planned and ensured smooth execution of electrical box build production on time, within budget, and to the required quality standard. Coordinated with cross-functional team to prepare plan and production strategies, resource strategies, BOM, and RMA to meet business and fiscal goals. Ensured assurance of assembly manufacturing launches and product delivery. Identified KPIs and reported potential risks in product plans. Monitored job orders, adjusting schedules to control costs and meet priorities. Projects included Lam Research AKT 100K, combos, 25K, and Applied Material’s ETCH power box.

• Improved manufacturing runtime and quality standards through collaboration with customers, engineering, supply chain, and assembly lines to plan and manage new projects, logistics, and production tasks.

• Ensured continuous operations by coordinating with buyers to check raw material movement, new BOM for NPIs, and supply chain issues in product cycles.

• Avoided shortages and excesses through supporting best practices in supply chain control techniques. Dart Neuroscience, San Diego, CA – R&D Product Manager 09/2010 –04/2014 Participated in identifying protein targets for drug discovery, development of high-throughput drug-screening assays, and medical chemistry for compounds to treat cognitive and motor disorders and enhance brain function. Member of team that developed new drug mechanisms to identify genes in mammals that responded transcriptionally during long-term memory disorders. Projects included PDE-4, MAO-B, and GLyT1.

• Completed clinical phase 1 of PDE-4 inhibitors and pre-development discovery of GLyT1 transporter. Zeltiq Aesthetics, Pleasanton, CA – Product Manager 12/2007 – 09/2010 Supported and coordinated development of quality programs for NPIs (medical devices) from design to final process, including execution process, product improvements and quality completion of operational tasks. Collaborated with internal and external stakeholders. Worked primarily on CoolSculpting medical device, focusing on launching products through FDA regulations, EU MDD, MDSAP, premarket approval (510K), clearance, and in-vitro clinical trial regulations.

• Ensured new product compliance with applicable US and global regulations, as well as company’s quality policy, via collaboration across departments to develop new product quality program. Affymax, Cupertino, CA – Quality Assurance Manager 08/2002–12/2007 Handled company compliance and document management system by following ISO9000 and FDA CFR21 part 11,820,210. Maintained QMS and the document control for CAPAs, NCs, RMAs, NPIs, and Validation Document Control for drug libraries discovery, synthesis peptide, and drug screening development (Omontys - anemia treatment). Participated in quality validation (IQ, OQ, PQ) projects to streamline and improve document structure, templates, and processes in manufacturing. Managed a team of 2 quality associates.

DiaDexus, S. San Francisco, CA – Lab Operations Manager 03/1998 – 05/2002 Directly managed day to day activities of molecular biology lab, maintaining QMS, document control, providing QC inspections for all in-vitro diagnostic kit products (cardiac biomarkers, biomarker colon cancer), DNA Sequencing and Peptide Synthesis. Participated in setting overall safety standards, and training. Handled the implementation of QMS (G2 Stack) for QA document control, data storage system, and QA compliance documentation. Ensured all product deviation and RMAs properly investigated. Supervised 5 quality associates. Projects included QMS-G2 Stack implementation, Document Control System implementation, and In-Vitro diagnostic kits testing. ADDITIONAL INFORMATION

USA Citizen

5th Dan Black Belt Master Taekwondo – Founder of Than Phong Silicon Valley Taekwondo Non-Profit Organization EDUCATION

Coursework, Master of Business Administration (MBA), Bellevue University, Bellevue, NE Bachelor of Science, Business Administration and Management (BSBA), Bellevue University, Bellevue, NE Bachelor of Science (BS), Biology, San Jose State University, San Jose, CA Associate of Science (AS), Business Administration and Management, Mission College, San Jose, CA CERTIFICATION

Lean Six Sigma Green Belt

Internal Auditor

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