Quality Assurance Assistant (m/f/d)

The Quality Assurance Assistant supports QA activities for sterile medical devices in accordance with ISO 13485, Regulation (EU) 2017/745 (EU MDR), Regulation (EU) 2017/746 (EU IVDR), applicable sterile medical device requirements, approved procedures, and the site Quality Management System (QMS).

The role contributes to maintaining product quality, sterility assurance, contamination control, traceability, data integrity, and user/patient safety by supporting documentation review, QMS processes, quality investigations, audits, training coordination, validation-related activities, and inspection readiness under QA supervision.

The position works closely with Quality Assurance, Production, Regulatory Affairs, and other relevant functions to ensure that quality and compliance requirements are consistently followed and that potential quality risks, deviations, or nonconformities are promptly escalated.

Quality Assurance Support for Sterile Medical Devices

• Support QA oversight of sterile medical device manufacturing, packaging, labelling, storage, and release-related activities in accordance with approved SOPs, quality requirements, and technical documentation.
• Review production, packaging, sterilization, environmental monitoring, cleaning, and traceability records for completeness, accuracy, legibility, and compliance prior to QA approval or product release, as delegated.
• Verify that sterile handling, cleanroom qualification, segregation, labelling, and contamination control practices are consistently followed.
• Promptly escalate quality risks, nonconformities, deviations, or potential compliance issues to the appropriate QA or operational stakeholders.
• Assist with the initiation, documentation, tracking, investigation, and closure of deviations, complaints, CAPAs, and change controls in accordance with Serana’s Quality Management System.
• Support QA checks for incoming materials, components, packaging materials, supplier documentation, and approved supplier requirements.
• Maintain accurate, contemporaneous, attributable, legible, complete, and reliable GMP/GDP records.
• Support validation activities, internal and external audits, and regulatory affairs documentation, as required.
• Verify correct product and material identification, status labelling, storage conditions, segregation, lot/batch traceability, and UDI or labelling-related information where applicable.

Quality Management System, Documentation & Data Integrity

• Assist in the preparation, review, distribution, filing, and archiving of controlled documents, forms, records, specifications, and quality procedures within the QMS.
• Support the maintenance of accurate and up-to-date quality documentation in accordance with applicable GMP/GDP, ISO 13485, and internal requirements.
• Ensure documentation practices comply with data integrity principles, including accuracy, completeness, traceability, contemporaneous recording, and proper correction of records.
• Support continuous improvement of documentation workflows, record management, and QMS-related administrative processes.

Skills, Qualifications & Certifications Required

• Bachelor’s degree in Life Sciences, such as pharmaceutical sciences, biotechnology, chemistry, biology, or a related discipline.
• Prior experience in Quality Assurance, Quality Control, sterile production, cleanroom operations, sterilization, packaging, or medical device manufacturing is preferred.
• Strong theoretical knowledge may be considered in place of prior experience, particularly within an ISO 13485, GMP, or similarly regulated environment.
• Basic understanding of sterile medical device QMS requirements, contamination control, cleanroom principles, CAPA, change control, documentation practices, and risk management.
• Good command of both English and German, written and spoken.
• Strong attention to detail, structured working style, and ability to fo