Quality Engineer - WA - DEC2024

Keltia Design Inc
  • Snohomish, WA
    2 days ago

    Job Description

    Location

    Snohomish WA - 2213

    Position Id

    EB-1999448781

    Job Type

    Full-Time Regular

    Quality Engineer - Snohomish WA Area - 2213

    Our client in the Snohomish WA area is a fast-growing contract manufacturer specializing in medical device implants and instruments who is looking for a Quality Engineers

    Requirements:

    • Degree in Quality or Degree in Science / Engineering.
    • Experience within a similar role as quality engineer.
    • 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
    • The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
    • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
    • Knowledge of GD&T
    • Knowledge of lean concepts
    • Ability to understand and solve problems.
    • Proven track record in managing a manufacturing quality system with measurable results
    • Knowledge of advanced manufacturing, quality assurance, quality control, and related measurement methods and techniques
    • Knowledge of product inspection standards and sampling, metrology and tools calibration preferred
    • Experience in using statistical data analysis methodology to control and improve the design, product realization (manufacturing) and supply chain related processes
    • Knowledge of supply chain processes and supplier quality management programs for government and prime contractors purchasing, contracting and subcontracting
    • Ability to specify, negotiate and document agreements related to supplier quality requirements
    • Experience in developing, implementing and managing/leading an effective MRB (material review board) program
    • Ability to lead an effective continuous improvement program (or be part of the team that is responsible) related to both products and processes
    • Ability to interact well with and manage people as well as facilitate interdisciplinary teams
    • Adapts quickly to changing requirements, resources, and tools
    • Superior leadership, communication and interdisciplinary skill

    Duties:

    • Works with customers, program managers, and engineering staff to develop techniques and procedures for inspecting and testing company product to meet customer requirements
    • Responsible for developing and implementing inspection, test and calibration operations & supporting customer, regulatory & compliance audits
    • Oversees analysis on material or product defects, production processes, and customer requirements/specifications in order to recommend or implement modifications in products and/or quality standards where appropriate, including implementing work instructions
    • Manages product deviation requests and other customer quality notifications.
    • Support and continually improves the Quality Management System
    • Partners with engineering to manage the document control process
    • Establishes effective communication channels that ensure the flow of quality-related information to and from vendors, customers, management, and other departments
    • Identifies and develops new quality metrics as needs arise
    • Assists in development of strategic and tactical plans to ensure achievement of company and departmental goals

    If interested, please send your updated resume in Word doc format to varsha@keltia-design.com with preferred pay requirements and availability and we will follow up immediately.

    Apply

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    Numbers & Facts

    LocationSnohomish, WA

    Skills

    • Calibrationunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Contract Manufacturingunmatched
    • Contract Negotiationunmatched
    • Customer Support/Serviceunmatched
    • DEC Computersunmatched
    • Data Analysisunmatched
    • Develop Methodologiesunmatched
    • Document Controlunmatched
    • Document Managementunmatched
    • Drug Manufacturingunmatched
    • FDA (Food and Drug Administration)unmatched
    • Geometric Dimensioning and Tolerancingunmatched
    • Government Contractsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Implantsunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Managementunmatched
    • Manufacturing Systemsunmatched
    • Materials Analysisunmatched
    • Medical Equipmentunmatched
    • Metrologyunmatched
    • Operational Supportunmatched
    • People Managementunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Product Designunmatched
    • Product Developmentunmatched
    • Product Managementunmatched
    • Product Planningunmatched
    • Product Testingunmatched
    • Product/Service Launchunmatched
    • Purchasing/Procurementunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Sampling Inspectionunmatched
    • Statisticsunmatched
    • Strategic Planningunmatched
    • Supply Chainunmatched
    • Testingunmatched
    • Vendor/Supplier Quality Managementunmatched

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