QA Device Manager – Maternity cover (12 months)

Does it excite you to work with combination product devices, and do you have experience providing QA guidance for device development and external partners? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.Your new positionZealand Pharma is looking for a QA Device Manager to join our Manufacturing QA team in a 12-month maternity cover (fixed-term) role. The position is primarily focused on device regulation and quality system compliance, with emphasis on ISO 13485 and QMSR. The role supports device and combination product activities from early development to commercial readiness in an outsourced business model, requiring strong collaboration with internal stakeholders and external suppliers/partners.We Offer Exciting ResponsibilitiesSet direction for device quality and compliance in development projects in line with ISO 13485 and QMSR requirementsProvide timely QA guidance to device and combination product activities supporting investigational programsCollaborate closely with Zealand’s device development organization and external device partners/suppliers to ensure compliant executionDevelop, maintain, and improve device and combination product QMS documentation (e.g., SOPs and related controlled documents)Support inspection readiness and partner audit preparation, and drive continuous improvement and simplification of quality processesYour profileThe ideal candidate has a strong quality mindset, works independently, and builds effective relationships across internal functions and external partners. The role requires structured execution, clear communication, and the ability to translate regulatory requirements into practical and compliant ways of working. GMP knowledge is considered a plus, but is not required.Master’s degree in life science, engineering, pharmaceutical sciences, or similarSeveral years of experience with medical devices and/or combination products in the pharmaceutical or medical device industrySolid working knowledge of ISO 13485 and quality system requirements; familiarity with QMSR is requiredExperience from Quality Assurance in device development settingsStrong stakeholder management skills and ability to collaborate in an outsourced setup with suppliers and partnersExcellent written and verbal communication skills, with a structured and solution-oriented approachYour new teamYou will be part of Manufacturing QA, a dedicated QA team supporting device and combination product activities for development and commercial products. The team works as quality assurance partners in an international environment with internal stakeholders and external companies to ensure continuous compliance. This position is a 12-month maternity cover, starting preferably May 1, 2026.Let's bond and be boldWe have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.Interested in bonding with us? Then please apply no later than March 15, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.For further information, please contact Head of Manufacturing QA, Martin Wallin mwallin@zealandpharma.com.We are committed to an inclusive recruitment process and welcome applications from all job applicants.About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.