QA Logistics Manager/Specialist EMEA

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

They are a global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives.

Role Description

Provide strategic leadership in the area of quality for all internal warehouses and Third Party Logistic companies for the EMEA region. Provide leadership, vision training and mentoring for the internal logistics EMEA Department and Third Party Logistic company in order to ensure compliance to Company quality system and applicable standards. Develop and implement quality systems for all activities linked to warehousing and Distribution at an EMEA level. Responsible for ensuring compliance with regulatory requirements and systems/procedures to optimize internal and external device manufacturing, and device distribution.

Responsibilities

• Provide strategic leadership in the area of quality for all internal warehouses and Third Party Logistic companies for the EMEA region:
Establishes strong quality processes at the Third Party Logistic Companies (3PL) and EMEA internal warehouses regarding manufacturing, storage and distribution of biological products;
- The current 3PL warehouses are situated in: The Netherlands, Spain, UK and Ireland;
- The current internal warehouses are situated in Portugaland South Africa.
Interacts with different internal and external stakeholders at management levels such as plant manager of the warehouse, EW SCM and EW Manufacturing
• Quality representative for the Warehouse & Distribution activities within EMEA.
• Manages investigation and resolution on complex manufacturing product quality and compliance issues; Manages creation, validation, and improvement of manufacturing processes/methods; manages optimization of complex Manufacturing processes using engineering methods
• Provide strategic leadership on Projects impacting the EMEA Warehouse & Distribution network implementing new processes from conception to deployment including Risk Management, Control, Documentation

Requirements

• >5 years related experience in a regulated environment, preferably medical device or pharma industry.
• Proven knowledge of GMPs, FDA, QSR and ISO regulation and standards, in particular ISO13485.
• Good understanding of Good Warehousing Practices within the Medical Device Industry.
• Proven knowledge of Quality related tasks within the medical device industry like validation, risk analysis, quality control plans
• AQC or ISO 13485 Lead Auditor Certified preferred
• Six Sigma Certification preferred

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