Senior Quality Engineer
Location: United KingdomSIRE® 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 Surrey United Kingdom.
- Write audit reports and follow-up on corrective actions that result from supplier audits
- Issue Supplier Corrective Action Requests, Supplier Performance Reports, and use other tools available to monitor and improve supplier quality
- Develop innovative approaches to supplier management as necessary to meet business needs
- Independently make decisions on supplier’s performance to specified requirements
- Troubleshoot incoming and production identified discrepancies and work directly with suppliers to obtain and track corrective actions to prevent further defects
- Serve as Quality lead with contract manufacturers/packagers supporting quality and business goals
- Provide input to qualification and validation plans and continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations
- Knowledge of supplier quality principles
- Strong knowledge of regulatory requirements including CFR 820 and ISO 13485
- Effective in root cause analysis, design of experiments and statistical data evaluations
- Experience in high volume manufacturing and/or medical device manufacturing is desired
- Strong computer skills including the use of Microsoft Word, Excel, PowerPoint
- Lead auditor certification required
- Six-Sigma Black Belt, or ASQ CQE, or equivalent preferred
- Experience in SAP ERP systems is a plus
- Effective written and verbal communication skills (English).
- Understanding of legal, FDA and ISO requirements for medical devices, including standards and guidelines for validation of equipment/facilities, processes and product
- Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical abilities
- Ability to make sound quality decisions under pressure
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
Our client is a global Medical Device company in SurreyRole Description
Senior Quality EngineerResponsibilities
- Plan supplier audits for new and existing suppliers as required by business objectives and established schedule- Write audit reports and follow-up on corrective actions that result from supplier audits
- Issue Supplier Corrective Action Requests, Supplier Performance Reports, and use other tools available to monitor and improve supplier quality
- Develop innovative approaches to supplier management as necessary to meet business needs
- Independently make decisions on supplier’s performance to specified requirements
- Troubleshoot incoming and production identified discrepancies and work directly with suppliers to obtain and track corrective actions to prevent further defects
- Serve as Quality lead with contract manufacturers/packagers supporting quality and business goals
- Provide input to qualification and validation plans and continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations
Requirements
- Higher Degree (BS equivalent) in the Sciences, Engineering or in Life Sciences with 5 years experience- Knowledge of supplier quality principles
- Strong knowledge of regulatory requirements including CFR 820 and ISO 13485
- Effective in root cause analysis, design of experiments and statistical data evaluations
- Experience in high volume manufacturing and/or medical device manufacturing is desired
- Strong computer skills including the use of Microsoft Word, Excel, PowerPoint
- Lead auditor certification required
- Six-Sigma Black Belt, or ASQ CQE, or equivalent preferred
- Experience in SAP ERP systems is a plus
- Effective written and verbal communication skills (English).
- Understanding of legal, FDA and ISO requirements for medical devices, including standards and guidelines for validation of equipment/facilities, processes and product
- Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical abilities
- Ability to make sound quality decisions under pressure
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
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