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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.