Job Openings >> Quality Engineer II
Quality Engineer II
Summary
Title:Quality Engineer II
ID:1890
Department:Quality
Location:Norwalk, OH
Description
PURPOSE/SUMMARY

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.

PRIMARY DUTIES AND RESPONSIBILITIES
  • 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
SUPERVISOR RESPONSIBILITIES 

None

MINIMUM QUALIFICATIONS 
  • 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.
PHYSICAL DEMANDS

Stand/Sit/Walk 8 hrs a day

WORK ENVIRONMENT

Chemicals/Solvents
Clean Room
Infectious Disease exposure
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CONTACT US
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
The OEM trademarks identified herein are the trademarks of the respective OEMs, and not Nissha Medical Technologies. Nissha Medical Technologies disclaims any affiliation, connection or association between it's products and those of the respective OEMs.