Quality Engineer 3

Posted Yesterday
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Melbourne, FL, USA
In-Office
Senior level
Hardware • Healthtech • Software
The Role
Develops and improves quality assurance systems, inspection plans, sampling methods, and corrective actions for electro-mechanical products. Performs audits, root cause analysis, SPC and KPI analysis, dimensional inspections, nonconforming material disposition, and MRB leadership. Supports supplier quality, quality planning, Lean continuous improvement, and compliance with applicable quality, medical device, and manufacturing standards. Uses metrology equipment and statistical methods to ensure products meet design and customer requirements.
Summary Generated by Built In

 The Quality Engineer is responsible for developing, evaluating, and improving Quality Assurance processes, procedures, specifications, and for monitoring product and process performance throughout the life-cycle of Sun Nuclear Corporation (SNC) products including the use of statistical process control (SPC) tools.

 

Key Areas of Responsibility: 

General/Processes

  • Assists in establishing, implementing, and maintaining quality management system including manuals and procedures.
  • Develops training to build quality awareness and competency throughout SNC.
  • Responsible for continual improvement activities to enhance the quality system (Lean methods such as Kaizen). 
  • Conducts inspections/audits, root cause analysis, creates reports, and executes corrective and preventative actions (CAPA).
  • Other duties as assigned by Management.

Quality Planning

  • Uses metrology equipment and statistical methods to ensure that the product meets design requirements, Quality plan criteria (First Article, Incoming, In-Process, and Finished Goods), and other specifications defined by SNC and its customers.
  • Analyzes design drawings and critical requirements to define inspection requirements and procures quality tools/fixtures.
  • Develops sampling plans by applying attribute, variable, and sequential sampling methods.

Supplier Quality

  • Provides technical expertise to assure adequate supplier process controls are implemented and maintained.
  • Supports supplier selection and evaluation process for new/existing products and materials.

Quality Inspection    

  • Supports the Quality Inspectors to ensure that products and processes comply with relevant requirements of the quality management system and performs inspections when necessary.
  • Analyzes and dispositions Non-Conforming material including containment, scrap, return, rework, sort, and release of product.  Leads Material Review Board (MRB) activities.
  • Visual and Dimensional inspection of Electro-Mechanical parts, assemblies, and products.  Determines root cause for dimensional concerns and identifies sources of variation within production environment.

 

Skills & Experience: 

  • Knowledge of geo-dimensional mechanical inspection and electro-mechanical inspection including proficiency in the use of manual and visual inspection equipment (including programming of Micro-Vu Vision Measurement Equipment); calipers, micrometers, digital indicators, surface plates, optical comparators, microscopes, CMM, AOI equipment, and profilometers.
  • Lean Manufacturing (or Six Sigma) experience.
  • Familiar with IPC-A-610, IPC-7711, IPC-A-600, ISO 9001, ISO 13485, FDA21 CFR 820, EC MDD 39/42, and/or CA SOR 98/282.
  • Basic understanding of statistical quality assurance methods (SPC) and be able to collect, analyze, and communicate the impact of the data collected during the inspection process (including Quality KPI and trending analysis).
  • Knowledge of problem solving techniques including 5 Whys, Fishbone, PFMEA, DFMEA, SPC, Pareto, 8-D, and PDCA.

 

Academic Requirements:  

  • A bachelor's degree in Quality, Mechanical Engineering, Industrial Engineering or 5 years equivalent work experience.
  • Professional certification from the American Society for Quality (ASQ) is preferred.

Skills Required

  • Bachelor's degree in Quality, Mechanical Engineering, or Industrial Engineering, or five years of equivalent work experience
  • Experience with geo-dimensional mechanical and electro-mechanical inspection
  • Proficiency with manual and visual inspection equipment, including calipers, micrometers, digital indicators, surface plates, optical comparators, microscopes, CMM, AOI equipment, and profilometers
  • Programming experience with Micro-Vu Vision Measurement Equipment
  • Lean Manufacturing or Six Sigma experience
  • Familiarity with IPC-A-610, IPC-7711, IPC-A-600, ISO 9001, ISO 13485, FDA 21 CFR 820, EC MDD 39/42, and/or CA SOR 98/282
  • Basic understanding of statistical quality assurance methods, including SPC, quality KPI analysis, and trending analysis
  • Knowledge of problem-solving techniques including 5 Whys, Fishbone, PFMEA, DFMEA, SPC, Pareto, 8D, and PDCA
  • Professional certification from the American Society for Quality (ASQ)
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The Company
HQ: Melbourne, FL
370 Employees
Year Founded: 1984

What We Do

Sun Nuclear provides independent quality-management solutions for radiation therapy and diagnostic imaging centers, supporting patient safety across cancer diagnosis and treatment. Its portfolio includes radiation-therapy QA equipment, diagnostic-imaging phantoms, dosimetry systems, and associated software for healthcare settings. The company’s mission is to enable healthier lives by improving cancer avoidance, detection, and treatment; its integrated solutions are used by cancer centers worldwide.

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