System One is seeking candidates for a Sr.

Quality Engineer position with a medical equipment

manufacturing company in Melbourne, FL. This is a full-time, direct hire position.

Key Areas of Responsibility:

 Manage design and production relationships to ensure product integrity and continuously
improve manufacturing performance.
 Partner cross-functionally within Operations as well as with R&D to drive continuous
improvement, eliminate known issues, and reduce potential risks.
 Provide guidance to Quality Inspectors, conduct product inspections, and process audits.
 Assist in developing, implementing, and maintaining procedures and manuals for the Quality
Management System.
 Identify and lead Continuous Improvement opportunities, such as Lean Process Improvements
(elimination of waste), 5S Improvements, and Mistake Proofing.
 Manage nonconforming material including containment/communication, dispositioning,
approval, and timely closure.
 Analyze and report on quality metrics (ex: Quality KPIs) to identify trending issues and develop
improvement opportunities.
 Participate in and drive adequate Root Cause & Corrective Action (RCCA) for necessary hardware
and process issues.
 Review and analyze product designs and critical requirements to identify and minimize potential
manufacturing risks through mistake proofing, process controls and inspection methods.

Qualifications/Experiences:

 Bachelor's degree in either Industrial Engineering, Quality/Manufacturing Engineering,

Mechanical Engineering, or similar technical field, with a minimum of 5 years Quality related
work experience.
 Lean and/or Six Sigma experience (Six Sigma Greenbelt or Blackbelt certified is preferred).
 Exceptional problem-solving skills are a must. Working knowledge and experience in effective
problem-solving methods for Root Cause / Corrective Acton (RCCA) and investigative techniques
such as 5-Why analysis, Fishbone Diagram, 8D method, and data analysis.
 Basic understanding of risk assessment techniques such as DFMEA/PFMEA, Control plans, and
SPC.
 Ability to perform trend analysis and transform data into information to assist leadership into
making impactful decisions.
 Familiar with IPC, ISO, and FDA standards.
 Capable of interpreting mechanical drawings (machined, cast, and injection molded parts).
 Working knowledge and understanding of GD&T (Geometric Dimensioning and Tolerancing).
 Experience with First Article Inspections (FAI).
 Proficient in data automation and metric development through applications such as Microsoft
Excel and Access.
 Proficient in the use of manual and visual inspection equipment.