QSM/Engineer Assistant – Sealwerks

  • by
Location
Candidate No.
1965664

About this Candidate

DAVRON CV: Candidate 1965664

QUALITY ENGINEER | SUPPLIER & MANUFACTURING QUALITY | QMS, CAPA & VALIDATION

Core Expertise

  • Supplier qualification and audits assessing manufacturing capabilities and process controls.
  • Led root-cause investigations and CAPA using 8D, 5 Whys, Fishbone, and Pareto analysis.
  • Managed nonconformance investigations, material disposition, containment, and customer complaint resolution.
  • Applied GD&T and tolerance stack-up analysis to validate component fit, form, and function.
  • Executed IQ/OQ/PQ equipment validation and Gage R&R to verify measurement systems.

Project Background

  • Qualified suppliers for mechanical and electromechanical components supporting high-volume production.
  • Supported new product introduction and production transfers with engineering and procurement collaboration.
  • Implemented supplier corrective actions and continuous improvement to reduce repeat defects.
  • Performed supplier audits and developed corrective action plans to improve supplier quality performance.
  • Used Excel and Power BI to track supplier KPIs, trend analysis, and scorecards.

Key Skills

  • Quality Management Systems | ISO 9001 | ISO 13485 | 21 CFR Part 820
  • Supplier Quality | Supplier Audits | Supplier Qualification | Supplier Scorecards
  • CAPA | 8D | 5 Whys | Fishbone | Pareto Analysis | Root Cause Analysis
  • GD&T | Tolerance Stack-Up Analysis | Engineering Drawing Review | FMEA | Control Plans
  • Validation: IQ/OQ/PQ | Gage R&R | Measurement System Analysis
  • Data tools: Microsoft Excel | Power BI

Education

  • M.S., Business Analytics — Trine University
  • B.S., Mechanical Engineering — Osmania University

Why Interview this Candidate?

They offer hands-on supplier and manufacturing quality experience in regulated environments, combining supplier audits, CAPA leadership, GD&T, and equipment validation. Proven track record resolving nonconformances, reducing repeat defects, and supporting NPI and production transfers through cross-functional collaboration and data-driven KPI tracking. Ready to contribute immediately to QMS, supplier quality, and continuous improvement initiatives.

LEARN MORE

If this sounds like a candidate that you'd like to speak with, contact us for more information. It's always free to review resumes and set up interviews! We only charge a fee if you hire one of our candidates. Not who you are currently searching for? Send us a job description and we will begin a dedicated search right away, at no obligation!


Contact