Job Openings >> Quality Engineer II
Quality Engineer II
Title:Quality Engineer II
Location:Norwalk, OH

Provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development, procurement, manufacturing, returns and servicing of products produced.

  • Cross Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
  • Completes assigned Quality Engineering tasks to schedule.
    • Promotes awareness of Quality and Regulatory requirements.
    • Leads or participates in the development of process and procedure development/changes.
    • Applies statistical process control (SPC) methods to evaluate current processes and process changes.
    • Develops new approaches to solve problems identified as part of the team.
  • Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures.
  • Trains location personnel on all aspects of the Quality System and regulatory standards.
  • Applies the requirements of the Quality System to processes, products or services for the location.
    • Supports the manufacturing line to address quality issues and resolution.
    • Provides support to metrology and preventive maintenance programs.
    • Supports validation and verification strategy for new and existing products and processes as assigned.
    • Leads the development and maintenance of Master Validation Plans.
    • Participates in the CAPA process as required as an assignee or project team member.
    • Investigates escalated product complaints to root cause to ensure timely customer response and correction.
    • Monitors product and process performance metrics and acts upon trends (positive or negative).
    • Leads MRB as a team member to ensure proper disposition of nonconformances.
    • Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
    • Conducts internal, vendor, and process audits to schedule.
    • Interfaces with suppliers to resolve Quality issues.
  • Develops and drives measurable Quality improvements relating to products, processes and services.
  • All other essential related duties as required


  • Bachelor#s degree inE ngineering discipline or equivalent.
  • Three to eight year#s relatede xperience and/or training; preferably in the medical device industry related to process/quality engineering.
  • Knowledge of basic mechanical testing and material properties.
  • Knowledge of metrology.
  • Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements.
  • ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA).
  • Working knowledge of problem solving skills # good statistical and analytical skills.
    • Working knowledge of Problem Solving Tools (i.e. Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
    • Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean, Six Sigma, etc.)
  • Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management
  • Proven Project Management skills.
  • Proficient in the use of Information Technology and applications.

Stand/Sit/Walk 8 hrs a day


Clean Room
Infectious Disease exposure

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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
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