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.

Role Description

In this role, you have the opportunity to be part of the dedicated Quality team. The Quality department focusses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.
By joining this organization, you will be part of the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.

Responsibilities

• Accountable for ensuring full quality and regulatory compliance for his/ her unit(s)
• Taking charge and participate in multidisciplinary improvement,
• Proactively participate in daily direction of his/ her units like MRB (Material Review Board), escalations (production stop), PPG’s, supplier meetings, daily commcell,
• Maintaining and improving performance via Quality tools and techniques,
• Ensures site audit readiness and hosts the quality system audits,
• Performs internal audits in the units on applicable procedures, regulations and instructions,
• Proposes corrective measures for the audit findings and follows progress,
• Stimulates and implements tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, PPA,
• DMAIC, problem solving methods, statistical process control, 5S + 1,
• Process, validate and close QN’s (Quality Notifications) in SAP and NC (Non Conformity) documents,
• Reviews and approves DHR (Design History Record) before final release,
• Reviews and approves DMR (Device Master Record) and DHF (Design History File) before release,
• Supports timely and correct closure of CAPA’s and ensures compliancy in his unit,
• Monitoring Quality of incoming goods, and the improvement of those goods.
• Adhere to company procedures and maintain compliance with FDA QSR regulations and ISO 13485:2016 standards.
• Perform other quality related duties as assigned.
• Providing support ensuring external audit readiness and during external audits/inspections
• Defines, establishes, monitors and improves training on internal auditing

Requirements

• HBO level (mechanics or electronics),
• 4+ years within quality assurance or quality control within an operational environment (preferably medical devices, automotive or aerospace),
• Knowledge of tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, problem solving methods, statistical process control, 5S + 1, PPA or APQP, DMAIC,
• Process minded and able to make and optimize procedures and supporting documents,
• Excellent analytical, problem solving and root-cause analysis skills
• Ability to present issues to a management level,
• Excellent communication and reporting skills in Dutch and English.
• Character: people-oriented, no-nonsense, pro-active, make-it-happen mentality, pressure-resistant, able to get things done from people, disciplined.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.