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Quality Engineer

3.00 to 5.00 Years   Salem   28 Jan, 2020
Nordson
Job LocationSalem
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

  • Provide the technical quality knowledge and support required to maintain continuous improvement within a regulated medical device environment.
  • Ensure adherence to customer and regulatory requirements are maintained at all times. Use quality tools to facilitate lean and a culture of continuous improvement.
Essential Job Duties and Responsibilities
  • Assure compliance with FDA Quality Systems Regulation, ISO Standards and SOP s as defined by Nordson MEDICAL (NH), Inc. policies, practices and procedures.
  • Apply Quality Engineering techniques on new and/or existing products. Assure all products meet or exceed customer requirements.
  • Support product teams in the implementation of Lean/Cost Saving Initiatives.
  • Represent Quality in production process efforts, quality planning, FMEA and Risk Analysis.
  • Participate in IQ/OQ/PQ validation activities including the drafting, review and execution of protocols.
  • Apply statistical tools such as Process Capability, Measurement System Analysis and Statistical Process Control to assess and improve production processes.
  • Handle customer complaints including the implementation of problem-solving actions to ensure product quality. Maintain all required documentation for closure.
  • Support the QC Department in the proper documentation and disposition of non-conforming product.
  • Work with departments to assure thorough Corrective Action problem-solving implementation.
  • Review product and process changes to ensure proper documentation and actions related to risk assessment are completed.
  • Train Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product, procedures and measurement techniques.
  • Lead or participate in internal/external Quality System audits.
  • Maintain effective working relations, communications and feedback with all other departments.
  • Other duties as assigned
Education and Experience Requirements
  • Bachelor s Degree and/or 3-5 years of experience in Medical Device Manufacturing Environment
Skills and Abilities
  • Knowledge: Statistics, Minitab, SPC, Risk Assessment, ISO 13485, Lean Manufacturing. ASQ Certification preferred.
  • Problem Complexity: Develops resolutions to problems of limited scope. Follows standard practices and procedures.
  • Freedom to Act: Work is closely managed. Follows specific, outlined and detailed procedures
  • Impact: Contributions are usually limited to assignment-related activities.
  • Liaison: Contacts are primarily with direct supervisor and other exempt professionals in the group/department.
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Keyskills :
equalemploymentopportunity isostandards iso13485 iso continuousimprovementfacilitation qualitytools measurementsystemanalysis qualitycontrol calibration statisticalprocesscontrol sdepartmentofagricultureusda

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