Supplier Quality Engineer - 28298BR - EN in Kalamazoo, MI at Stryker Corporation

Date Posted: 5/15/2018

Job Snapshot

Job Description

Supplier Quality Engineers (SQEs) work with component suppliers, contract manufactures, and original equipment manufacturers, to ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations. SQEs act as a technical liaison between suppliers, Engineering, Purchasing, and Manufacturing, to support projects and to resolve quality issues. SQEs work under close supervision, and specific direction is provided by more experienced staff. SQEs must balance a workload of sustainment quality resolution, with execution of strategic development initiatives, in order to deliver improved supplier performance for Stryker Operations. The top two performance objectives for this role are: (1) ensure compliance, and (2) drive continuous improvement with Stryker suppliers.

Responsibilities related to compliance:
  • Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations.
  • Work with suppliers to quarantine all suspect and non-conforming material.
  • Issue supplier corrective action requests, and drive suppliers to identify and address true root cause.
  • Participate on supplier audits, as required.
  • Train/educate suppliers on GMP, regulatory requirements, and Stryker expectations.

Responsibilities related to sustainment:
  • Ensure an un-interrupted supply of conforming components to Stryker Operations.
  • Root cause analysis of part related manufacturing defects and warranty concerns
  • Manage supplier initiated changes; serve as the “change owner” in Stryker’s change management system.
  • Update prints and generate Engineering Change requests.
  • Update gage plans and attribute charts.
  • Serve as a subject matter expert, for your assigned commodity; share expertise within global Stryker organization.
  • Support manufacturing transfer projects.
  • Support strategic sourcing projects
  • Disposition material quarantined in MRB.

Responsibilities related to development:
  • Foster strong relationships with Stryker’s supplier-partners.
  • Analyze non-conformance data to prioritize projects and to solve systemic supplier issues.
  • Create and execute supplier development plans.
  • Drive continuous improvement actions with suppliers to reduce part related defects.
  • Evaluate and qualify of new suppliers, especially those with advanced technologies, to support product innovation.
  • Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection.
  • Make pro-active supplier site visits.
  • Train/educate suppliers on Quality topics: Quality System, problem solving, validation, and lean.
  • Push “lessons learned” from the supply base back to R&D for incorporation into next generation designs.
  • Must be able to generate, follow and explain detailed quality procedures.
  • Must be able to plan, organize, and implement multiple concurrent tasks.
  • Must be able to work independently; motivated to perform at a high-level without constant supervision.
  • Must possess the ability to understand business processes and how changes impact these business processes.
  • Experience in Quality, Project Management, or Engineering preferred.
  • Experience in medical device industry preferred.
  • Experience working onsite developing suppliers preferred.
  • Collaboration, negotiation, and conflict resolution skills.
  • Ability to lead, champion change, and execute strategies to meet goals.
  • Critical thinking and strong analytical skills.
  • Experience in production and process controls.
  • Strength in problem solving and root cause analysis.
  • Familiarity with quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts.
  • Working knowledge of statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability.
  • Process familiarity in assigned commodity (i.e. plastics, metals, electronics, PCBAs, etc.)
  • Excellent communication skills, verbal and written.
  • Excellent time management and organization skills, with high emphasis on attention to detail.
  • Advanced working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint.

Job Requirements

  • BS in engineering, or engineering related discipline, or equivalent work experience required.

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