Quality Manager

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Medical Devices organization, based in Zuid-Holland Netherlands.

Mid-Size Medical Devices company.

ROLE DESCRIPTION

As Manager Quality Assurance you are responsible for maintaining and continuously improving the QMS so it complies with the international requirements for manufacturers of medical devices. Think of:

- ISO 13485
- Medical Device Directive (93/42 / EEC)
- 21 CFR820
- CMDCAS
- PMDA

RESPONSIBILITIES

- Meet the (international) quality standards, laws and regulations;
- Up-to-date quality management system
- Report to management regarding quality, adherence to quality requirements, procedures and results of improvement;
- Supporting the operational departments in the areas of quality
- Advising on and supervising projects outsourcing, vendor selection and OEM projects.
- Monitoring and reporting on progress; Coordinating, implementing and / or supervising internal and external audits;
- Monitor the complaints, including vigilance, completion of field safety corrective actions
- Initiating corrective and preventive actions (CAPA's), based on Root Cause Analysis, and monitoring the progress, quality, reporting and implementation;
- Trending and monitoring of quality in the field of process control, and environmental conditions, inter alia Bioburden and Environmental Monitoring;
- Representing QA in multi-disciplinary teams at all stages of product development including risk management (ISO 14971);
- Drafting and reviewing validation protocols and reports and release of products.

REQUIREMENTS

- Technical WO / bachelors degree
- Minimum 5 years relevant work experience, preferably in the (medical) instruments
- Good knowledge of international regulations and standards eg ISO 13485, Medical Device Directive (93/42/EEC), 21 CFR820 (USA), CMDCAS (Canada), PMDA (Japan), RDC 16/2013 (Brazil) and experience with consultations international government agencies include the FDA, PMDA is required ANVISA;
- Good communication, consulting and managerial skills, both internally all external customer focus;
- Organization Consciousness can switch between management and workplace situations can sense and evaluate, create clarity and courage to take decisions;
- Knowledge and skills in the areas of quality, Lean and project management, quality tools (5 why, SPC, Ishikawa, Pareto, A3 methodology);
- English and Dutch speaking and writing

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