Quality Specialist (60-100%)

h3Open Position in Urdorf, Switzerland /h3 h3QUALITY SPECIALISTbr/(60-100%) /h3 h3We are looking for a Quality Specialist for our Quality Assurance Regulatory Affairs team /h3 p Back to job openings /p pSecurecell is a Swiss technology company at the intersection of biotechnology, engineering, and healthcare. For more than three decades, we have been developing innovative solutions that help advance scientific discoveries and improve people's lives. Combining deep expertise in bioprocess control with a strong culture of innovation, we collaborate across disciplines to transform complex challenges into practical technologies that create real-world impact. /p pContinuing steadily on our sustainable innovation path and growth journey, we are looking for a /p h3QUALITY SPECIALIST (60-100%) /h3 pfor our Quality Assurance Regulatory Affairs team /p h3THE OPPORTUNITY /h3 pThis is more than just a job. It is an opportunity to contribute to technologies that support groundbreaking scientific discoveries and help shape the future of biotechnology and healthcare. /p pAs a Quality Specialist, you will play a key role in ensuring the quality, compliance, traceability, and accessibility of documentation and quality records supporting innovative biotechnology and medical technology products throughout their lifecycle. Working closely with colleagues across Engineering, Operations, and Project Management, you will help maintain the highest quality standards while supporting the successful delivery of products and solutions to customers worldwide. /p pWhether you are improving existing technologies, driving innovation, or solving complex technical challenges, your contributions will have a direct impact on our success and future growth. /p pYou will be part of our Quality Assurance Regulatory Affairs team and be responsible for the creation, maintenance, control, and continuous improvement of quality and project documentation. In this role, you will oversee document control activities, support quality inspections and, coordinate quality records, and contribute to the ongoing development and effectiveness of our Quality Management System. /p h3WHAT YOU WILL DO /h3 ul liOrganize, coordinate, and manage project-related documentation throughout its lifecycle, including review, release, publication, and archiving /li liPerform Incoming Quality Inspections, in-process controls, and Factory Acceptance Tests (FAT) according to approved procedures and specifications /li liCreate, review, and maintain Quality Management System (QMS) documentation and project-specific quality records /li liGather, compile, and consolidate technical information by collaborating with cross-functional teams, suppliers, subject matter experts, and external partners /li liSupport the preparation and maintenance of technical documentation, including work instructions, operating manuals, test plans, reports, and technical files /li liEnsure project and quality documentation is accurate, compliant, and readily retrievable in both electronic and paper formats /li liContribute to the continuous improvement of documentation processes, tools, and quality-related practices /li liProactively communicate potential issues, deviations, and documentation gaps to project leaders and line management /li liProvide administrative and documentation support to project and quality teams as required /li liCollaborate closely with Production, Project Management, Systems Engineering, and other stakeholders to ensure quality and compliance objectives are achieved /li liSupport quality assurance activities and continuous improvement initiatives across the organization /li /ul h3WHO YOU ARE /h3 pYou enjoy solving complex technical challenges and thrive in an environment where electronics, embedded software, sensing technologies, and medical innovation come together. You are proactive, hands‑on, and motivated to develop technologies that improve blood parameter monitoring and diabetes care. You are comfortable working under pressure, operating with high visibility toward senior management, and collaborating within cross‑functional and agile teams. /p h3YOUR PROFILE /h3 ul liBachelor’s degree in Engineering, Life Sciences, Biotechnology or a related technical discipline /li liMinimum 4 years of professional experience in Quality Assurance, Quality Control, Documentation Control, or Technical Writing within a regulated industry /li liExperience working in Biotechnology, Medical Devices, Pharmaceuticals, or other highly regulated environments /li liProven experience creating, reviewing, and maintaining controlled documentation within a QMS environment /li liFamiliarity with quality inspection activities, in-process controls, and testing documentation /li liStrong technical writing and documentation management skills /li liExcellent organizational skills with a high level of attention to detail and accuracy /li liStrong knowledge of Microsoft Office and modern document management tools /li liAbility to work effectively with multidisciplinary teams and manage multiple priorities simultaneously /li liExcellent written and spoken English; German is an advantage /li liAvailability to work primarily on-site to support production, project teams, and quality activities /li liSwiss work authorization or eligibility to work in Switzerland /li liWe accept direct applications only (no agency submissions) /li /ul h3WHAT WILL MAKE YOU SUCCESSFUL /h3 ul liA passion for quality, accuracy, and well‑structured documentation /li liA proactive and solution‑oriented mindset with a strong sense of ownership /li liThe ability to work independently while effectively collaborating with diverse stakeholders /li liStrong communication skills and confidence interacting across departments and organizational levels /li liA highly organized and structured working style with exceptional attention to detail /li liAn analytical approach to problem‑solving and process improvement /li liThe ability to manage competing priorities and maintain high‑quality results under deadlines /li liA continuous improvement mindset and willingness to challenge existing practices constructively /li liExperience supporting projects traceability /li liA collaborative attitude and commitment to helping teams achieve shared goals /li /ul h3WHY YOU'LL LOVE WORKING AT SECURECELL /h3 pbMake an Impact: /bYour work contributes to innovative technologies that support scientific progress, improve healthcare outcomes, and help address real-world challenges /p pbWork with Exceptional People: /bJoin a global team of talented scientists, engineers, software developers, and business professionals who are passionate about innovation and collaboration /p pbGrow Your Career: /bWe encourage continuous learning and provide opportunities to develop new skills, expand your expertise, and take on new challenges /p pbInnovate Every Day: /bBe part of cutting‑edge projects and help develop solutions that push the boundaries of biotechnology, automation, and healthcare technology /p pbTake Ownership: /bWe believe great ideas can come from anywhere. You'll enjoy a high level of responsibility, autonomy, and the opportunity to make a visible contribution /p pbEnjoy a Collaborative Culture: /bOur success is built on teamwork, knowledge sharing, mutual respect, and a genuine passion for solving complex challenges together /p pbBe Part of Our Growth Story: /bJoin a growing Swiss technology company where innovation, entrepreneurship, and long‑term thinking are at the core of everything we do /p h3WHAT WE OFFER /h3 pWith flexible working arrangements, a modern workplace, flat hierarchies, and short decision‑making paths, we empower individuals to take ownership, contribute ideas, and make a visible impact. Our culture is built on trust, collaboration, and continuous improvement, allowing every team member to help shape the future of our company and the industries we serve. To complement this, we offer: /p ul liCompetitive compensation aligned with your experience and contribution /li liComprehensive benefits package supporting your well‑being /li liGenerous vacation entitlement, flexible working hours, and hybrid or remote work options /li liFlexible leave arrangements that support work‑life balance /li liLearning and development opportunities through training, mentoring, and hands‑on experiences /li liOpportunities to collaborate with international customers and partners /li liConvenient location with direct access to public transport, free indoor parking, complimentary coffee and mineral water /li liPrivate accident insurance and paid time off for new parents /li liEmployee share purchase programs (availability varies upon eligibility) /li liRegular team events and company gatherings that strengthen connections and celebrate success /li /ul h3JOB LOCATION /h3 pThis position is at Securecell AG headquarters in Urdorf (Zurich), Switzerland. /p h3INTERESTED? /h3 pWe look forward to learning more about you! /p pPlease note: Applications submitted by recruitment agencies will not be considered! /p h3Questions? - Contact Our Recruitment Teambr/ /h3 pLara Lucentini Global HR Partner /p p(c) Securecell AG, Urdorf, Switzerland /p #J-18808-Ljbffr