Supplier Quality Engineer

Location: Netherlands

SIRE® 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.

The Company

A leading health technology company focused on improving people's lives through Innovation, a systematic approach and a path to value is how they distinguish themselves. An organisation with an international character and a lot of opportunities to develop yourself and grow.

Role Description

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.

Responsibilities

• 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) requirements.
• Drive quality and compliance development and/or improvement at suppliers when needed; 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 ‘’One Philips’’ towards Supply Base in the assigned BG or Market.

Requirements

• 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.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.