Supplier Quality Engineer # JN -012020-51032

Bothell, Washington
Industry: Database Administrator / Engineers
Job Number: JN -012020-51032

Your Challenge:

  • Perform Supplier Quality activities in the SQE team related to, as example, purchased part qualification with suppliers (APQP), supplier quality issue resolution (QN, SCAR) and ensuring appropriate incoming material inspection strategies. Drive quality activities with suppliers, setting a high standard and fast response expectation to solve issues and control and prevent. Collaborate across functional areas of amongst others R&D, Manufacturing, Procurement and lead with best practices to enable our organization to provide high quality medical products to our customers

Your Responsibilities:

  • Manage Supplier Quality related activities for purchased materials for electro-mechanical commodities such as printed circuit board assemblies (PCA’s), power supplies, cables, battery packs, plastics, sheet metal, machined parts, OEMs (displays, medical assemblies), labeling, etc.
  • Work with suppliers through the BIUs APQP process to ensure all necessary quality activities are rigorously addressed during initial product release and change such as: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R, MSA, line release, ramp monitoring, etc.
  • Ensure supplier test strategy aligns with quality goals. Focus on quality issue resolution via an 8-D based Supplier Corrective Action request process. Resolve quality issues via structured quality methods in order to ensure efficient and effective root cause analysis, and corrective / preventive actions that ensure there is no recurrence
  • Execute supplier audits, CAPA’s and monitor supplier metrics. Orchestrate first article inspection / first production inspection, and ongoing inspection plans that are aligned with supplier’s capabilities, quality history and our product needs. Support key processes as subject matter expert

Job Requirements:

  • Successful candidates for the Supplier Quality Engineer position have high level knowledge of the regulations: 21 CFR 820, ISO 13485 and ISO 14971. Strong APQP background, SQE experience and someone with a questioning attitude, able to prioritize and execute tasks in a dynamic environment, will excel in this role

Additional requirements include:

  • Bachelor’s Degree in Mechanical or Electrical Engineering
  • Demonstrated knowledge of manufacturing processes for commodities such as printed circuit board assemblies, power supplies, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc.
  • Experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. APQP / PPA / PSW, FMEA, DOE, IQ/OQ/PQ, TMV / MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures
  • Expert working knowledge of standards and regulations applicable to supplier controls affecting a medical device
  • Requires strong working knowledge of quality assurance principles and practices, industry and international safety standards
  • Minimum 7-years’ experience in medical device or pharma environment
  • Must possess excellent communication (verbal & written) skills
  • Must practice analytical problem solving skills
  • Working knowledge of various software packages including Microsoft (Excel, Word, Project, and SharePoint) and SAP applications is desirable
  • Knowledge of implementing testing frameworks
  • Highly organized with efficient use of time
  • Ability to facilitate collaboration with cross-functional groups development in a team environment
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