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Design Control, Risk Management, CAPA

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!


Our client is a professional Medical Devices organization, based in Hessen Germany.

My client is looking for three profesionals:

- Design Control Expert
- Risk Management Expert
- Validation/ CAPA Expert (Broad QA Role)


General QA Ops Eu/AP: Main purpose to:
- Provide QA Guidance, Subject Matter Expertise support execution of projects
- Lead QA related strategic projects;
- Provide Q- Support to business projects (Product Development, Technology & Engineering, products and/or technology transfers, expansion;
- Lead / participate in quality improvement projects;
- Determine QA deliverables for change projects and execute the related QA activities in a timely manner and in compliance with the regulations and our quality system;
- Improve Quality Systems and to roll out the improvements within the GO MD TT
- As QA expert to provide input and feedback to senior management / board questions;
- Support / lead / follow up of critical quality, compliance and/or vigilance topics;


Specific skills:
- Expert in applying Design Control, Risk Management and or Validations
- Knowledge of ISO standards ISO 9001 & 13485,
- Knowledge of Risk management (ISO 14971),
- Knowledge of the Medical Device Directive (MDD),
- Experience with the QSR and CFR (FDA)
- Experience in change management
- Project management skills.
- Root cause analysis
- Pre: 6 sigma and lean experience
- Pre: Statistical know how
- Pre: Knowledge of validating sterilization processes
- Pre: knowledge of Gamp


Social skills:
Professional, analytical, responsible, reliable, enthusiastic, convincing, proactive person with a hands on mentality and who has a seniority on QA-topics and project leadership.

Maintain contacts:
- Internal: project teams, directors of business partners, senior management, operations, T&E, R&D, product management
- External: suppliers, customers, notified bodies.

Job requirements
- Minimal 4 years work experience in the medical device industry
- Minimal 4 years QA experience
- Affinity with QA-topics, technology, product design and medical devices
- Professional, responsible, reliable, enthusiastic, proactive person with a hands on mentality and who has a seniority on QA-topics and project leadership
- Able to work in cross functional teams
- Fluently English (speaking & writing),
- Ability to lead projects / activities
- Willingness to travel
- Good communicator; capable to communicate at different levels (with senior management, marketing units, RA experts, local employees)
- Higher professional technical education (University/HBO))
- Pre: Familiar with Lean, Six Sigma methodologies (Black Belt)
- Pre: speaking German

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.

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