Supplier Quality Engineer
For the ECR project we are looking for a Supplier Quality Engineer
The organisations’ Global Supplier Quality Team works with a worldwide supply base and our global Business Innovation Units (BIU’s) to help ensure high quality purchased materials. The team leads Supplier Quality Engineering activities during new product development, purchased material quality issue resolution and ongoing supplier quality monitoring.
Perform Supplier Quality activities 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 so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers.
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 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.
To perform this job successfully, an individual must have the necessary skills and be intrinsically motivated on supplier quality topics. The requirements listed below are representative of the knowledge, skill, and/or ability required:
• BS Engineering degree and minimum of 7 to 10 years industry experience in manufacturing of electro-mechanical systems/products/solutions for the medical, aerospace or automotive industries
• 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. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures.
• Knowledge of the Purchasing function and associated commodity, supply base, quality and data management considerations. Understanding of Procurement, Supplier Relationship Management, Material and Supplier Quality and Data Management areas.
• Effective communicator. Able to work effectively with global, cross-functional stakeholders.
• Experience in a regulated environment, medical preferred.
• Certified auditor for ISO13485 or 9001.
• Knowledgeable in SAP Quality Management, Oracle Data Warehouse, Mini-Tab, Query tools such as Business Objects, web-based systems, and MS Excel (power user).
• CQE, six-sigma Black Belt or Green Belt.
Furthermore to be successful in this role you are :
• Motivated, self-driven with a determination to succeed and the ability to manage change.
• Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.
• Fluent in English
• Willing to travel regularly to Bothell, WA, US.
Please send us asap your recent CV + a motivation for this role, both in English, together with your availability/planned vacations and all-in hourly rate VAT (BTW) excluded.