Quality System Specialist
SIRE Life Sciences®
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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 Brussels Hoofdstedelijk Gewest Belgium.
The CompanyOur client is a professional Medical Devices organization, based in Brussel Belgium. As a medical company, they contribute to society by providing valued products and services in the healthcare market and by responding to the needs of patients and healthcare professionals.
To make this happen, their goal is to innovate within their work, deliver new value to the medical frontlines and remain committed to our vision: Innovating at the Speed of Life.
Role DescriptionAs part of this department, the main responsibilities of the QS Specialist are to support the organisation to comply with the applicable quality system standards by following the quality system requirements and supporting the implementation, by organising and performing quality audits and lead the follow up of all related non conformities and by active participation in process improvements. You will focus on our UK plant in Liverpool. The first 3 months, intensive travel will be required to our plant in Liverpool, later this we be 15% of your time.
Responsibilities1. Execute and support quality systems audits
• Follow up of standards and regulations for audits
• Participate in the internal audits
• Support regulatory and corporate audits
2. Coordinate quality measurement and improvement in CV plant
• Lead improvement project to ensure that all Quality System processes are performed in accordance with the defined requirements.
• Train associates in the related Quality System process requirements and e-QMS system.
• Support reply on questions of regulatory authorities.
• Responsible for process non conformity handling (including audit non conformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity.
• Coordinate and follow up of process monitoring and trend analyses – review need for improvement actions or CAPA and follow up implementation with the organisation.
3. Maintain the Quality Management Systems in the organisations
• Support the Quality Systems responsible with the implementation and maintenance of the quality management systems and procedures applicable to medical devices.
• Participate in review of procedure updates and review of documents/files
• Support implementation of change control projects
• Implement and follow up monitoring tools like KPI’s to measure process performance
Requirements• University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
• Experience in medical and/or pharmaceutical field as an advantage
• Minimum 3 years of experience in quality department (QA or QS)
• Knowledge of the Quality Standards ISO 9001, ISO 13485 or FDA 21CFR part 820; and/or audit experience
• Willing to travel on a regular basis for short trips (CV plant located in UK)
• Excellent working knowledge of English (written and spoken). Knowledge of Dutch is an advantage.
• You are a hands on person, and prefer this approach above a theoretical approach. You are present on the floor.