Careers

 

Position: Supplier Quality Engineer (Sr.)

Status: Regular, Full-time, Exempt, Redmond, Washington

Job Summary: Provide Quality System leadership, expertise, guidance and assistance to the Supply Chain and Engineering teams.

Position Responsibilities:

  • Provide support for all Supplier Quality Assurance activities.
  • Monitor, analyze, and report on supplier performance.
  • Conduct on-site quality system audits and surveys in support of supplier management requirements.
  • Assist Supply Chain and Engineering in new supplier selection and assessment activities.
  • Develop supplier certification and dock-to-stock strategies.
  • Assist personnel and suppliers in formation of valid statistical sampling plans and inspection procedures for incoming materials.
  • Recommend appropriate measurement tools and processes for inspection.
  • Coordinate Supplier Corrective Action Requests and assist suppliers where necessary using sound problem solving tools.
  • Assist in analyzing floor rejections and receiving inspection rejections to determine cause for failure and provide trend data.
  • Support Receiving Inspection in metrology and product specification issues.
  • Other projects as assigned.

Position Qualifications:

  • BSME or equivalent experience in a medical device environment.
  • Seven or more years of experience in a Supplier Quality Engineering position, in a medical device manufacturing environment.
  • Knowledge of 21CFR Part 820 and ISO13485 requirements.
  • Blueprint reading, Geometric Dimensioning and Tolerancing, and precision measurement techniques.
  • Analytical, technical writing and verbal communication skills.
  • Certified Quality Auditor (CQA) certificate and/or Certified Quality Engineer (CQE) certificate preferred.
  • Familiarity with standard quality improvement tools, including statistical methods.
  • Strong problem solving skills in a mechanical assembly environment.
  • Interpersonal skills and ability to work effectively in a cross-functional team.
  • Effective written and oral communication with all levels of EGS and supplier personnel.
  • Self-directed; ability to plan, organize, and initiate supplier-related processes.
  • Standard Microsoft Office software, other PC software as required.
  • Travel up to 30% of time, in the first six months.
  • Occasional time in a controlled environment room following appropriate gowning procedures.
  • Routine activity in the Receiving Inspection laboratory.
  • Possible exposure to biologically contaminated product and cleaning materials.

Equipment to be used in Performance of Job:

  • Computer/laptops/printer
  • Blackberry/cell phone
  • Fax Machine
  • General office equipment

E-mail résumés to hr@endogastricsolutions.com or send to:

HR Manager
EndoGastric Solutions, Inc.
8210 154th Avenue NE
Redmond, WA 98052