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    Principal Supplier Quality Engineer - Westborough, United States - Olympus

    Olympus
    Olympus Westborough, United States

    5 days ago

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    Description

    Job Description

    The Principal Supplier Quality Engineer is responsible for the product/service-related supplier quality within defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning. They are specialized in a product group/category and supports the supplier quality engineering team locally and regionally with technical and process knowledge in the category.

    Job Duties

  • Develops quality assurance strategy for sourced products.
  • Acts as supplier quality engineering representative in new product development projects.
  • Coordinates and ensures the external component qualification/FA process.
  • Identifies gaps in suppliers' capabilities / technical project risks.
  • Takes decisions on acceptance or rejection of sourced materials.
  • Guides inspectors regarding incoming inspections (e.g. training, standards, etc.).
  • Leads improvement projects at the supplier.
  • Performs material related supplier change management activities.
  • Acts as primary interface to supplier regarding product related quality matters.
  • Analyzes product related supplier quality issues.
  • Is part of the material review board.
  • Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP).
  • Performs product and process audits at the supplier and initiates appropriate measures, where required.
  • Performs Product Qualification Process by applying the appropriate methods.
  • Advanced Product Quality Planning (APQP).
  • Performs local supplier management such as supplier approval, supplier auditing, QAA negotiation and supplier evaluation if delegated by Supplier Quality Manager (SQM).
  • Is specialized in a product group/category and supports the supplier quality engineering team locally and regionally with technical and process knowledge in the category.

    • Job Qualifications

    Required:

  • Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
  • Demonstrated expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP
  • Knowledge of and minimum 5 years' experience in supplier quality engineering
  • High level of quality tools and methodology skills (e.g. 8D, 5-Whys, FMEA, IQ/OQ/PQ, APQP)
  • Very good written and oral communication and organizational, project management skills.
  • High degree of technical knowledge within the process/category supported
  • Very good knowledge of Quality tools and methods ISO 9001 / FDA / Medical technology background.
  • High degree of qualification in specific product group.
  • Advanced English .
  • 20% travel should be expected.
    • Why join Olympus? Here, people matter—our health, our happiness, and our lives.
  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**
    • *US Only **Limited locations
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