Title: Contracted Supplier Quality Engineer
12 months extendable
This is a temporary opportunity located in Bothell, WA (Seattle area)
Client is manufacturer of Automated External Defibrillators, is looking for a Supplier Quality Engineer to work in a scrum team. A scrum team is a dedicated cross-functional project group with the goal to tackle and solve high priority business / operational issues.
Perform Supplier Quality activities in the dedicated scrum team related to purchased part qualification with suppliers, supplier quality issue resolution 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.
Scrum is not a process or a technique for building products, but is a framework within which you can employ various processes and techniques. In an agile environment, team members collaborate and support each other to meet their Sprint Commitments. The emphasis is on the right attitude, not just aptitude. In fact, by collaborating and sharing tasks, team members can often deepen and broaden their skill sets.
Successful candidates for the Supplier Quality Engineer position have high level knowledge of the 21 CFR 820, ISO 13485 and ISO 14971. 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
• 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 5-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
Thanks and Regards,