Supply Quality Engineer
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
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. 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.
A minimum of 5 years in QA/RA with a high preference in supply QA management
Working knowledge of Medical Device standards and regulations ISO 13485 (and ISO 9001), FDA 21 CFR 820, MDR
Lead auditing in ISO 13485 is a big plus
The Company
They are an international Healthcare/Medical Device manufacturer and distributor operating globally. One of their sites is placed in Eindhoven where they are currently looking for a Supplier Quality Engineer.Role Description
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 minimised. Lead with best practices to enable our organisation to provide high quality medical products to our customers.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.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. 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.
Requirements
A Bachelor degree or higherA minimum of 5 years in QA/RA with a high preference in supply QA management
Working knowledge of Medical Device standards and regulations ISO 13485 (and ISO 9001), FDA 21 CFR 820, MDR
Lead auditing in ISO 13485 is a big plus
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