Technical Documentation Specialist
vor 1 Woche
Our customer is as an immunoassay provider focusing on specialty diagnostics. The company has over 30 years of experience in the development, manufacture, and supply of immunoassays - including enzyme, radiolabelled, and luminescence-based assays - for routine diagnostics and research.
We are looking for a biology laboratory assistant, alternatively CTA/ BTA/ MTA (or comparable) in the field of immunoassay production as a Technical Documentation Specialist (M/F/d) in Hamburg.
Role Requirements:
- Coordination and project management of design changes for the creation of technical files for the implementation of the IVDR according to QMH in consultation with Head of Product Development or Technical Documentation Manager.
- Creation and maintenance of technical files for in-vitro diagnostic products including DHF and DMF.
- Preparation and maintenance of risk management documents for in-vitro diagnostic products including risk analyses, PMPF and PMS.
- Coordination of processes within the design changes with Product Managers, Production, Quality Control and QA / RA.
- Submission of technical files to the notified body, handling of queries.
- Independent planning, execution, and evaluation of performance measurements to complete the technical documentation or within the scope of design changes.
- Technical guidance of Product Development Technicians within the scope of the assigned project.
- Preparation / follow-up and participation in audits (FDA, BSI, other authorities).
- Production of required reagents and samples for the performance measurements.
Your profile:
- Successfully completed vocational training as a biology laboratory technician, alternatively CTA/ BTA/ MTA or comparable.
- At least 1-3 years of relevant professional experience in the development and technical documentation of in-vitro diagnostic products in accordance with ISO 13485, ISO 14971, IVD Directive 98/79/EC.
- High scientific and technical understanding.
- Very good language skills: German and English.
- Analytical, creative, and solution-oriented way of thinking.
- Independent way of working.
- Coordination and organisational skills;team player.
- Project management skills.
You can expect an exciting, dynamic environment with a high degree of personal responsibility and initiative. You will work in a committed team with extensive social benefits in an internationally active company.
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