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Quality Engineer

Requisition Number: POS2569

Region: US
State: Wisconsin
City: Menomonie


Provide support on new product introduction (NPI) at our largest medical manufacturing facility! 

  • Core responsibilities: Purchased Part Approval Process (PPAP), Molding Validations, Batch Records and Validations, and Drug related deliverables
  • Lead development and review of verification/validation plans and protocols
  • Measure validation process effectiveness and lead continual improvement of system
  • Communicate and coordinate activities including internal and external approvals of validations
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve
  • process for supplier data submission to reduce internal inspections
  • Participate in AQP meetings representing quality, where appropriate
  • Provide engineering team with information and analysis tools as needed
  • Facilitate communication between engineering function, manufacturing, and quality
  • Responsible for being a communication liaison between the customer and manufacturing facility
  • Extended travel to other facilities may be required to support business needs
  • Some programs may have vision requirements
  • Other duties as assigned

Qualifications - Education & Experience

  • Bachelor degree in an engineering discipline or equivalent.
  • Minimum 6 years quality/regulatory experience
  • Minimum  3 years auditing experience

Qualifications - Skills & Competencies

  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers
  • Strong communication (verbal and written), teamwork and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions
  • Experience with: Process Failure Mode Effect analysis, Build Requirements Documents, Purchased Component Quality Agreements, Inspection Plan Lot
  • Release documents, IQMS, MRB, Deviations, CAPA, Bill of Materials, Device Master Record, Verification/Validation, Test Method Development/Validation,
  • Batch Records/Review, Certificates of Conformance, Supplier Quality, Design of Experiments, Statistics, Sample Plans/AQL, Prints/Drawing/Specification,
  • GD&T, Gage R&R, First Article Inspection as examples.
  • Experience with: ISO 13585, ISO 14971, CFR 820, CFR 210, CFR 211


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