Supplier Quality Engineer
As a Supplier Quality Engineer you are the interface between the Innovation & Development team at Innovation Site Eindhoven and Manufacturing Suppliers.
In this role, you have the opportunity to implement and manage Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into the supply chain
• Partner with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.
• Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
• Ensure raw materials/components/products at supplier(s) are released from supplier(s) to the client according to the agreed requirements.
• Drive quality and compliance development and/or improvement at suppliers when needed; the face to supplier(s) on lean improvements.
• Ensure compliance to regulatory requirements and procedures for regulated products/processes.
• Ensure raw material and component specs and drawings are translated to supplier quality
Requirements, qualify suppliers, assess metrics of whether supplier products meet quality specifications, and audit suppliers critical to quality processes.
• Ensure that validations are completed where specified, and control plans exist to ensure the sustained quality and compliance of supplied raw materials and components.
• Ensure correction and prevention activities of suppliers are timely, effective and required communications and escalation.
• Create Supplier quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Executes SCAR management effective and timely closure and Review/risk assessment of QN's and their escalation to SCARs where needed.
• Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
• Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
• Independently works to deploy common approaches and working methods to drive towards Supply Base in the assigned BG or Market.
We are looking for
• Bachelor degree in an engineering or science discipline, or equivalent.
• Current certification with a recognized accreditation body (i.e. RAB- QSA/ IRCA) or successful completion of ASQ certification as a certified Quality Engineer (CQE) and certified Quality Auditor (CQA) or Certified biomedical auditor or successful completion of a recognized Lead Auditor Course.
• 8 -10 years of total industry experience with 4+ years of related experience in a medical device or regulated industry.
• Applied knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO13485, ISO14971, European Medical Devices Regulation, Japanese MHLW Ordinance 169 and ISO9001.
• Experience in root cause analysis, corrective and preventive action methods.
• Expertise / experience in problem solving with quality tools such as 6-sigma/ 8-D/ CAPA/ FMEA/ 5WHY etc.
Good Knowledge of production/ quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control plans, etc
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.