Ph3Open Position in Urdorf, Switzerland /h3 h3QUALITY ENGINEER /h3 h3We are looking for a talented Quality Engineer for our Quality Assurance and Regulatory Affairs department /h3 h3INNOVATION IS OUR PASSION /h3 pSecurecell is the trusted partner for biopharma, enabling them to bring new therapies to patients in a safe, efficient, and economical way. We innovate ground‑breaking measuring and control engineering technologies to radically improve bioprocessing, medical treatment, and patient health. For more than 25 years, we have been delivering innovative solutions in bioprocess control for biotech, pharma, and academia. This expertise and experience provided the foundation for the technology transfer into the MedTech space and the development of Seraccess, a truly disruptive diabetes therapy. /p h3QUALITY ENGINEER /h3 pYou develop, implement, and maintain the quality management system across the entire product lifecycle, ensuring compliance with applicable standards and regulatory requirements. You define and oversee quality processes, methods, and tools to ensure consistent product and process quality, contribute to verification and validation activities, and support audits (internal and external). /p pYou act as a key interface between stakeholders, including project management, RD, manufacturing, suppliers, and regulatory bodies, facilitating quality‑related communication, driving issue resolution, and ensuring alignment on quality objectives. You create, review, and maintain the necessary quality documentation, including procedures, reports, and records. /p pYou lead root cause analyses, implement CAPAs, and drive continuous improvement initiatives. You assess risks, hazards, and non‑conformities, ensuring appropriate mitigation strategies are defined and implemented, and capture lessons learned for ongoing and future projects. /p pYou monitor relevant standards, regulations, and industry best practices, incorporating them into the quality framework. You support business development and product strategy by providing quality‑related insights, ensuring that products meet market and regulatory expectations. /p h3YOUR TASKS /h3 ul liAct as the Quality Assurance specialist in biotech projects. /li liCoordinate and moderate risk management activities and ensure that defined risk control measures have been implemented. /li liPerform CR, CAPA, and NC activities in accordance with quality procedures. /li liDrive, create, and maintain the technical and end‑user documents for our hardware products through the entire product lifecycle. /li liWrite the relevant information in a form fulfilling the legal and normative requirements. /li liOrganize and coordinate documentation deliverables at the end of each project phase by interacting with document owners to define, create, and publish required deliverables to ensure that quality targets, timelines, and regulatory requirements are respected. /li liLead the eDMS system, contributing to the continuous improvement of documentation tools, including validation, user training, and serving as the key contact person. /li liGather, compile, and consolidate the information needed for technical writing by collaborating closely with departments, teams, suppliers, experts, and other third parties (both locally and globally). /li liSupport Quality Control activities in production. /li liCreate new processes relevant to the Quality department. /li liSupport the maintenance of the Quality Management System (QMS). /li liAct as a trainer for the documents created as an author or for other general training related to product documentation or compliance. /li /ul h3YOUR PROFILE /h3 ul liMin. bachelor’s degree in engineering, sciences, or similar with relevant proven experience in a technical area, preferably in Biotech, MedTech, or other highly regulated environment. /li li3‑5 years of experience in a quality role, preferably in a highly regulated industry. /li liInterpersonal, autonomous, flexible, and organized with an analytical and critical mind. /li liGMP knowledge and strong affinity for technology. /li liExcellent spoken and written command of English (native speaker or equivalent level), ideally good German knowledge. /li liCandidates must have the legal right to work in Switzerland. /li /ul h3OUR OFFER /h3 pSecurecell offers a highly diverse international working environment and the opportunity to collaborate with highly skilled individuals from various disciplines. Partnership and interdisciplinary collaboration are at the core of our company, our research activities, and the commercialization of our marketed products. We nurture true innovation and creative thinking to advance our research projects as well as to continuously improve our marketed products. At Securecell, you will discover a challenging job, inspiring colleagues, and a true purpose. /p h3JOB LOCATION /h3 pThis position is at Securecell AG headquarters in Urdorf (Zurich), Switzerland. /p /p #J-18808-Ljbffr