Quality Assurance Supervisor
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 and Pharmaceutical organization, based in Antwerpen Belgium.
Specialised Medical Devices company on Vascular, Urology, and Oncology products.
The QA supervisor is responsible for Quality Systems management in conjunction with the QA Management. He/she supervises and coordinates activities of QC inspectors engaged in inspecting, testing and reworking of incoming and outgoing goods. Work with QA Management to meet the Quality requirements.
Keep up to date and be involved in new product on loads, changes in procedures and processes. Implement quality improvement processes. Keep track of critical activities and projects and assist QA Management in tracking and reporting. The incumbent is responsible to maintain and improve processes linked to the quality system requirements per ISO 13485.
- Supervision of team of QC inspectors and QC coordinator to ensure, track and manage their productivity, professionalism and performance
- Ensure delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule.
- Maintain and improve the Quality System and is responsible to participate in the maintenance of the documentation management system, training management system, hold management process, and other Quality Control processes such as Receiving inspection and labeling activity.
- Implement quality improvement processes by working with interdepartmental teams
- Maintain product consistency throughout product cycle, through supply chain storage and handling phases through quality check points and testing.
- Support in the development of quality assurance metrics for performance improvement.
- Anticipate (release) problems and takes corrective action, escalating as needed, to resolve and achieve commitments.
- Provide effective communication regarding issues, objectives, initiatives and performance to plan.
- Responsible and accountable for flagging the timing of interdepartmental deliverables and the quality of their output.
- Manage validation program, for hardware and soft-ware, keep oversight and coordinates and performs required validation activities for changes and new implementations
- Manage non-conformance and CAPA program
- Take part in the internal audit program as lead auditor
Must have 3 years of Quality Assurance/Quality Systems experience either within Medical Device or Pharmaceutical organisation, manufacturing or distribution. Preferably prior experience in a supervisory position. Understand the CAPA management and non conformance management. Experience as auditor. Experience with process validation is an asset.
- Sound decision making based on knowledge of ISO regulations/ Quality system knowledge
- Trouble shooting/ problem solving - ability to provide practical solutions while maintaining compliance
- Enough knowledge of medical devices to understand the impact of his/her decisions
- Analytical (data analyses)
- Good interpersonal skills (people management)
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.