Metrology and Standardisation Officer
il y a 1 semaine
**Metrology and Standardisation Officer (2 year fixed term contract)**:
**Operations - Belgium**:
Department: Operations
Type: Temporary
Based: Hybrid
**Salary**:
Closing Date: 19/06/2024
IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
The Liege site was founded as a spin off from the University of Liege in 1989 and now houses 75 employees spread across operations, R&D and administrative functions. It is centre of excellence for the production and development of IDS automated assays and ancillaries for use on the IDS range of analysers. Here, we produce around 170,000 assay kits per year and have five R&D teams working on development projects related to automated assays.
Are you passionate about precision and quality within the medical device industry and thrive in dynamic environments where your expertise can make a tangible difference? We have an exciting opportunity for a Metrology and Standardisation Officer to join IDS and play a pivotal role in supporting us on some key projects to facilitate the launch of new products. As we embark on these exciting projects, we're seeking a skilled professional who can ensure the highest standards of accuracy and reliability in our measurement systems.
**Principle Accountabilities**
- Compliance Management: Ensure adherence to ISO13485, 21CFR, and GMP guidelines throughout all metrology and standardisation processes.
- Cross-functional Collaboration: Collaborate with R&D to assess and validate the reliability and accuracy of new product designs and technologies.
- Quality Assurance and Regulatory Compliance: Work closely with QA/RA teams to ensure that all metrology activities meet regulatory requirements and quality standards.
- Laboratory Testing: Perform a variety of metrology tests and analyses to verify product specifications and performance. This includes instrument calibration, measurement accuracy testing, and data collection.
- Documentation and Reporting: Maintain meticulous records of all metrology activities. Prepare protocols, reports, and documentation ensuring accuracy, completeness, and compliance with regulatory standards.
- Statistical Analysis: Utilise statistical methods to analyse metrology data and identify trends, variations, and potential areas for improvement.
- Continuous Improvement: Contribute to the enhancement of metrology processes and methodologies to optimise product quality and efficiency.
**Qualifications**
- Bachelor's degree in Biochemistry (or similar) with a minimum of 3 years of experience in a relevant field such as R&D, Metrology, or Quality and Regulatory Affairs within the medical device industry.
OR
- Master's degree in a relevant field with at least 1 year of experience in R&D, Metrology, or Quality and Regulatory Affairs within the medical device industry.
**Skills and
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