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Quality Director, Six Sigma, ISO13485

Location:
Wexford, PA
Posted:
March 25, 2025

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Resume:

Hao Wang

Cell Phone: 412-***-**** Email: *********@*****.***

Summary

Strive to be a strategic expert in quality and operation within the organization. Work with senior management providing Operational Excellence expertise to achieve business objectives.

Specialties/Skills

Risk Management, Lean, Six Sigma, Data Analysis, Medical Devices, ISO 13485, ISO 9001, DFSS, FEMA, SPC, CAPA, Change Control, FDA 21 CFR Part 820, GMP, Deviation Management, ISO 14971

Certification

Six Sigma Black Belt (American Society for Quality)

ISO 9001:2015 Internal Auditor

Six Sigma Greenbelt (Kennametal Lean Enterprise)

Experience

Quality Director, Advanced Energy (Apr. 2022 to current)

Division Quality Manager, UPS Division in Mitsubishi Electric Power Products Inc. (Oct. 2019 to Mar. 2022)

Quality Manager, Quality Engineer in Kennametal Corp. (Oct. 2012 to Oct. 2019)

Responsibility

The Quality Director develops and builds relationships with the customer and supplier from quality perspective in accordance with the mission and strategic goals of the organization. Lead multiple international teams to provide Quality support to R&D activities in BU, and global innovation process implementations. Plan and facilitate quarterly Business Review Medical BU and Plasma Power BU.

• Evolve and execute the annual strategic relations plan on quality designed to inform and support product and market strategy, and market positioning to drive pipeline and category leadership

• Develop, implement, and maintain the Global Deviations, Product Quality Complaints, CAPA processes to ensure compliance with regulatory, customer, and organizational requirements.

• Establish and lead user communities for the assigned process to collaborate with cross-functional teams to integrate quality processes into business operations

• Lead the development of and deployment of the systems and tools to drive innovation and continuous improvement within the Quality Management System

• Conduct vendor performance reviews, identify areas for improvement, and implement any corrective actions necessary

• Drive a culture of continuous improvement by identifying areas for enhancement in quality processes. Develop lesson learned library to implement best practices over all BU’s to enhance overall efficiency and effectiveness

• Be responsible for key Quality metrics: Customer Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics

Key Achievements

Harmonize the Product Development Process cycle across Medical BU and Plasma Power BU

Develop project plans and drive cross-functional program management of key reports and surveys from the industry, especially from key customers

Lead principle in new product development process improvement project. Key assist in global project team toward advancing regional processes toward unified level three systematic approach (SAP solution)

Completed 2 key Black Belt projects and actively managing one other; completed project to improve product performance on specific manufactured process, generating potential cost savings of more $230K.

Education

University of Pittsburgh, Materials Chemistry, PhD, 2012

Tsinghua University, China, Materials Science and Engineering, MS, 2007

Tsinghua University, China, Materials Science and Engineering, BS, 2005

Selected Publications/Patents

“Catalyst-assisted vertical growth of carbon nanotubes on Inconel coated commercial copper foil substrates versus sputtered copper films”, G. Atthipalli, H. Wang and J. L. Gray, Appl. Surf. Sci., DOI: 10.1016/j.apsusc.2013.02.071 (2013)

“Fabrication of discrete gallium quantum dots using focused ion beam on silicon substrate”, H. Wang and J.L. Gray,Nanotechnol., 22 425602(2011)

“Surface templates fabricated using a focused ion beam for lateral positioning of nanoscale islands on Si (001) substrates”, H. Wang and J. L. Gray, J. Vac. Sci. Technol. B, 29 04D106(2011)

“Control of Semiconductor Quantum Nanostructures: Variants of Si(x)Ge(1-x)/Si Quantum Dot Molecules”, J. Murphy, R. Hull, D. Pyle, H. Wang, J. L. Gray and J. A. Floro, J. Vac. Sci. Technol. B, 29 011029 (2011)

“Fabrication of Ga-templates Using a Focused Ion Beam”, H. Wang and J.L. Gray, Mater. Res. Soc. Symp. Proc. 1228, KK12 (2009).

“Progress in Research on High Temperature Piezoelectric Ceramics”, H. Wen, X. Wang, W. Zhao,H, Wang, L. Li, Z. Gui J. Chin. Ceram. Soc., 3411 (2006)

“Mid-Low Temperature Sintering of Ceramic Materials for Temperature-Stabled Multi-Layer-Ceramic-Capacitor”, X. Wang, R. Chen, C. Ma, Z. Lei, H. Wang, L. Li, Z. Gui, Patent of Invention Application Number- CN200410090868.1

Professional/Honorary/Other Memberships

AQS- American Quality Society, MRS- Materials Research Society, M&M- Microscopy & Microanalysis, SPE- Society of Petroleum Engineers

Computer Skills

Microsoft Office (Word, Excel, PowerPoint), Syteline, SAP, Extensive knowledge of MRP and ERP software/systems, Windows, Minitab, Northwest Analytics, Microcal Origin, Python, Gartner Magic Quadrants

Languages Proficient: English and Mandarin (Native Speaker)

Work Authorization: US Citizen



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