SQE - Supplier Quality Engineers

US-IL-Cary
6 months ago
Job ID
2017-26505
Category
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings
1

Overview

  • Senior Supplier Quality Engineers (SQEs) work in partnership with the Global Supplier Network. You'll be involved in the development of strategic suppliers and introducing business improvement initiatives that will help to ensure the external supply chain is capable of meeting expectations of quality, delivery, and cost to the Company. 
  • You will collaborate with Strategic Sourcing and other internal teams to understand the capabilities and competencies of suppliers with appropriate and sustainable infrastructure to meet product and regulatory requirements. You will partner with internal teams and suppliers to execute the appropriate development of continuous improvement programs at these key suppliers. 
  • Senior SQEs work under moderate supervision. 
  • Specific guidance can be sought from more experienced staff. 
  • Senior SQEs must balance a workload of quality problem solving and resolution, with execution of strategic development initiatives, in order to deliver improved supplier performance for the companyOperations. 
  • Senior SQEs are viewed as a team resource. 
  • Normally receives general direction on routine work and detailed instructions on new projects or assignments. 
  • Exercises judgment within defined procedures and practices to determine appropriate action. 
  • Demonstrates developing leadership skills. 
  • Will manage and develop suppliers defined as Strategic Business Partners. 
  • This role will involve teamwork with the SQE teams to ensure compliance to technical, regulatory, and Company requirements. The top performance objectives for this role are: (1) strategic supplier performance, and (2) strategic supplier capability development.

Responsibilities

Responsibilities related to Supplier Performance Improvement:

  • Develop strong, positive, and beneficial relationships with suppliers and Strategic Sourcing to create an overall supplier development program to drive strategic actions and projects related to Continuous Improvement approaches with our suppliers. 
  • Create and implement supplier improvement plans 
  • Analyze supplier performance data and metrics (e.g. DPM, failure modes, trending, etc.) 
  • Provide suppliers with comparative data and metric performance (e.g. Scorecard) 
  • Conduct annual and periodic performance reviews for assigned suppliers 


Responsibilities related to Supplier Ownership:

  • Partner with SQEs and Audit SQEs to understand performance and drive supplier strategy with Strategic Sourcing 
  • Execute supplier consolidation and manufacturing transfers to reduce cost, optimize capabilities, and improve quality 
  • Partner with Strategic Sourcing to participate in supplier selection 


Responsibilities related to Supplier Long-Term Development:

  • Lead selected projects for new process designs and existing process improvements by working with internal teams and suppliers to improve supplier’s processes, ensures the necessary process controls and documentation are in place to deliver high quality products that meets all Supplier Performance metrics and key process indicators (KPIs). 


Responsibilities related to Continuous Improvement:

  • Identify internal areas of process improvement in daily work and propose and implement changes 
  • Identify internal areas of systems improvement - propose and implement changes 
  • Participate in external audits and internal audits as needed to ensure Regulatory compliance in areas of responsibility to good manufacturing practices (GMP) of all medical devices regulatory agencies (i.e. FDA, IMB, Notified Bodies, etc). 
  • Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers.

Qualifications

  • Must be able to create, 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
  • 3+ years of experience in Quality, Project Management, or Engineering
  • Collaboration, influence, negotiation, and conflict resolution skills
  • Ability to champion change, and execute strategies to meet goals
  • Critical thinking and strong analytical skills
  • Familiarity with quality systems; ISO13485 & ISO9001 experience preferred
  • Strength in problem solving and root cause analysis
  • Familiarity with quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan preferred
  • Working knowledge of statistics: SPC, MSA, DOE, and Process Capability preferred
  • Excellent communication skills, verbal and written
  • Excellent time management and organization skills, with high emphasis on attention to detail
  • Working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint
  • BS in Engineering, or Engineering related discipline, required
  • ISO-13485 Lead Auditor certification preferred

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