As a Quality Officer you will support the QA Manager in maintaining a QMS that meets the applicable regulatory and company requirements (such as ISO 13485, EU In Vitro Medical Device Directive/Regulation (IVDD/IVDR), EN/IEC 62304, ISO 14971, etc.). You will manage the quality management system through processes in collaboration with other departments.
· Review documents (procedures, operating procedures, registration forms, specifications, protocols, reports, DMR) relating to raw materials, intermediate products, finished products as well as documents relating to manufacturing of packaging and analysis of kits.
· Provide assistance in drafting procedures, protocols, reports, change forms.
· Actively participate in the analysis and resolution of complaints in line with the customer's expectations.
· Participate in the registration, qualification and evaluation of suppliers.
· Write/review the specifications (Design Qualification), protocols and reports as part of validation or qualification activities (equipment, computer systems)
· Ensure Post Market Surveillance (PMS) review
· Participate in process/product validation and transfer activities.
· Ensure that corrective actions are implemented and monitored in the context of complaints, deviations, changes and results/products outside specifications
Ensure the framework and/or implementation of changes (process and/or design)
· Bachelor with scientific orientation (chemistry, biology, biochemistry, biotechnology, pharmacy).
Skills & Experience
· Quality Standards (EN ISO 13485, ISO 9001, ISO 14971, ISO Technical Standards), Legislation (Directive 98/79/EC), Good Practices (US FDA 21 CFR Part 820) and guidelines for the design and manufacture of in vitro diagnostic kits.
· In-depth knowledge of key processes of a quality management system (supplier management, training, deviations, CAPA, equipment, software, claims, audits, documents, etc.)
· In-depth knowledge of good documentary practices and manufacturing processes (production, packaging, analysis)
· Experience of at least 1 year in quality assurance and in an environment that respects good manufacturing practices (GMP)
· English spoken and written
What we offer:
Cultural Aspects – IDS Values
Passion for Customers – We are passionate in understanding our customer needs and dedicated to providing excellent solutions
Entrepreneurial – We consider the world around us as a set of opportunities, creating the chance to innovate and find solutions to generate customer and stakeholder value
Excellence – We strive for excellence in all we do, to deliver the best results in order to be best in class!
Respect – We show consideration for colleagues, customers and all business stakeholders, appreciating our diversity and respecting each other’s opinions