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 Noord-Holland Netherlands.
My client is one of the world leading Medical Devices.
- The Quality Management Systems (QMS) Specialist will be primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices.
- The QMS Specialist will oversee and support that an effective and efficient quality management system is built and maintained. Has responsibility to ensure all necessary QS regulations are met in order to receive regulatory clearance/ certification.
- You will be part of building the full Quality Management System - great project experience!
- 50% travel involved (around the world - North America, all of Europe, South America, China) Travelling is to other offices in these countries and occasionally to a supplier.
- Supports the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
- Contribute in developing optimum future state of QMS for business need, aligned with Corporate, divisional QMS.
- Identifies improvements & inputs into the quality planning process.
- Oversee and execute development and/or modification of regional/local Quality Management Systems.
- Co-ordinate Management Review and Quality Planning Review & Forums.
- Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
- Drive GMP and GDP practices within Quality.
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
- Develop & deliver training/compliance for QMS group.
- Contribute to the development, maintenance and improvements of the policies and procedures.
- Implement best in class QS practices and benchmark against industry leads and regulatory requirements.
- Liaise and communicate with notified bodies to manage certification changes.
- Ensure QMS reflects actual activities and business needs, and supports NPD requirements
- In a project environment, contribute to the development and/or modification of the companies regional/local Quality Management Systems.
- Can part take in information systems discussions' proficiently. Thinks about QMS from an IT perspective, proficient in SRS/URS contribution.
- Understands Quality Systems' & web based interactions.
- Proficiency in executing and leading projects, understands project stages.
- Proficient in improvement processes etc.
- Key contributor to the business process/es and understands how IT system supports those business processes
- Supports the business during audits to discuss system functionality.
- Has knowledge of the system integrations
- Supports the Business Process Owner/QA approver in IT change control assessment and approval on behalf of the business, with understanding of
change control requirements per regulatory and internal procedural requirements
- We are looking for a background such as Internal Auditor, Supplier
Quality auditor, QMS specialist, Quality Engineer or CAPA Specialist, or
- Great if you can bring in experience in building a QMS system (in medical
- Industry background: medical devices industry strongly preferred or
otherwise someone from a related
industry such as food or pharma
- Minimum Bachelor degree
- Training experience is very
- BS in a science,
engineering or related discipline.
- Minimum of 2 years of experience in Quality Management Systems
- Minimum of 5 years in Quality / Regulatory Affairs environment
- Experience working in a regulated environment required.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills. Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience in working in a compliance risk situation.
- Computer literacy.
- The role requires 50% of international traveling!
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.