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Gayatri Shirish Joshi

@gayatrishirishjoshi

I improve regulated manufacturing quality, validation, and production systems for medical devices and complex equipment.

United States

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What I'm looking for

I'm looking to improve manufacturing, quality, validation, and QMS systems in regulated or complex equipment environments, partnering across engineering, suppliers, and operations to deliver measurable quality, cost, and productivity gains.

At Helium Vacuum Tech, I design and optimize manufacturing and leak-testing processes for helium vacuum systems used across healthcare, automotive, and semiconductor applications. I establish QMS procedures, develop SOPs, and reduce technical, quality, cost, schedule, and delivery risks from design through final acceptance.

Previously at Zimmer Biomet, I supported Class II and Class III medical-device manufacturing under ISO 13485 and FDA regulations. I led CAPA, nonconformance, complaint, audit, supplier, and process investigations while supporting validation, change control, MRB reviews, and audit readiness.

I've also delivered manufacturing and quality improvements at AMETEK Reichert Technologies, CNH Industrial, and Seiler Garepa India. My work includes a $2M annual savings quality initiative, a 24% productivity improvement, and DOE-driven inkjet 3D-printing research that reduced cycle time by 34%.

Experience

Work history, roles, and key accomplishments

Current

Industrial Engineer

Current

Helium Vacuum Tech LLC

Feb 2025 - Present (1 year 7 months)

Conducted evaluations for helium vacuum leak testing in healthcare, automotive, and semiconductor industries. Designed and optimized manufacturing and testing processes, applied lean and Six Sigma tools, and established QMS procedures.

Lean Manufacturing Six Sigma Process Optimization Solidworks Autocad Minitab QMS CAPA Root Cause Analysis SOPs DFM Data Analysis

Manufacturing Engineer

Zimmer Biomet

Mar 2022 - Oct 2024 (2 years 7 months)

Provided quality engineering support for Class II and III medical devices in ISO 13485 and FDA-regulated operations. Led CAPA investigations, developed PFMEAs and control plans, and supported process validation and audits.

ISO 13485 FDA Regulation CAPA Fishbone Risk Assessment PFMEA Gage R&R Minitab Excel Supplier Audits SCAR

Quality Engineer

AMETEK Reichert Technologies

Nov 2021 - Mar 2022 (4 months)

Supported QMS compliance for medical and ophthalmic diagnostic products. Owned CAPA and root cause investigations, participated in MRB reviews, and improved process controls and traceability.

QMS CAPA Root Cause Analysis Engineering Change Control SOPs Audit Support

Quality Engineer

CNH Industrial

Jan 2021 - Nov 2021 (10 months)

Analyzed data and implemented quality tools to solve issues on manufacturing assembly lines, achieving zero defects and saving $2M annually. Led improvement projects using World Class Manufacturing and Lean methodologies.

Root Cause Analysis Lean Line Balancing PFMEA Data Analysis

Intern, Additive Manufacturing Lab

University at Buffalo

Jul 2020 - Dec 2020 (5 months)

Implemented Design of Experiments (DOE) to find optimal parameters for an NSF-funded inkjet 3D printing project. Collected and analyzed data to improve process accuracy and reduced cycle time by 34%.

Data Analysis Process Improvement

Quality Manager

Seiler Garepa India Pvt. Ltd.

Jun 2016 - Aug 2018 (2 years 2 months)

Managed engineering and manufacturing projects for helium leak-test systems and vacuum equipment. Improved productivity by approximately 24% through workflow standardization and bottleneck elimination.

Project Management BOM Manufacturing Planning Cross functional Coordination Productivity Improvement