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Sr Quality Engineer

Katalyst Healthcares & Life Sciences

  • Danvers, MA
  • 30+ days ago
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    Skills

    • American Society for Quality (ASQ)unmatched
    • Certified Quality Engineer (CQE)unmatched
    • Change Controlunmatched
    • Code of Federal Regulationsunmatched
    • Cost Analysisunmatched
    • Design Failure Mode and Effects Analysis (DFMEA)unmatched
    • Digital Rights Management (DRM)unmatched
    • Experiment Designunmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Industry Standardsunmatched
    • Inventory Managementunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Operationsunmatched
    • Medical Equipmentunmatched
    • Medical Office Administrationunmatched
    • Medical Productsunmatched
    • Procedure Implementationunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Process Qualityunmatched
    • Process Validationunmatched
    • Product Developmentunmatched
    • Product Lifecycleunmatched
    • Product Testingunmatched
    • Product/Service Launchunmatched
    • Production Controlunmatched
    • Quality Assuranceunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Six Sigmaunmatched
    • Six Sigma Green Beltunmatched
    • Statisticsunmatched
    • Support Documentationunmatched
    • System Validationunmatched
    • Technical Presentationunmatched
    • Technical Writingunmatched
    • Testingunmatched
    • United States Department of Energy (DOE)unmatched
    • Validation Testingunmatched
    • Writing Skillsunmatched

    Description

    Job Summary:
    • Senior Quality Engineer responsible for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
    • The role involves applying quality engineering principles across design, manufacturing, and product lifecycles while ensuring compliance with global regulatory standards.

    Roles & Responsibilities:
    • Provide Quality Engineering support for commercial medical device products.
    • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
    • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
    • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
    • Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
    • May specialize in areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
    • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
    • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
    • Present quality aspects during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation.
    • Present technical data to groups within and outside the organization.
    • Utilize quality tools including risk analysis (FMEA), statistical techniques including Six Sigma and DOE (Design of Experiments), root cause analysis, and reading and correcting drawings.

    Education & Experience:
    • Bachelor's Degree in Engineering, Science or technical field AND 5–7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
    • Medical Device Design & Development experience.
    • Risk Management experience including dFMEA, pFMEA, and statistical analysis.
    • Technical writing experience including IQs, PQs, TMVs.
    • Hands-on experience in upstream new product development and downstream manufacturing transfer and operations quality.
    • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016.
    • Demonstrated working knowledge of process validation, statistical methods, and risk management.
    • Green Belt Six Sigma/DRM Training/Certification preferred.
    • ASQ-CQE, CQA, CBA or equivalent certifications preferred.
    • SAP QM or SPC software experience preferred .

    Numbers & Facts

    LocationDanvers, MA

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