Global Quality and Medical System Manager

We are now offering an exciting opportunity for a Manager, Global Quality & Global Medical System. The preferred job location will be in any Scanfil office or factory: Poland (Sieradz, Myslowice), Finland (Vantaa, Sievi, Oulu), Sweden (Stockholm, Åtvidaberg, Malmö), Germany (Wutha), Estonia (Pärnu) with hybrid working flexibility and some international travel.As our Manager, Global Quality & Global Medical System, you will play a pivotal role in leading and developing Scanfil’s strategic operational quality framework across all factories worldwide. You’ll ensure alignment and compliance with global standards and regulations, including ISO 9001, ISO 14001, ISO 13485, MDR, FDA 21 CFR. Knowledge of Military standards is an advantage.You will support Scanfil’s organization with guidelines, methods, and tools to achieve operational excellence and continuous improvement—helping us move closer to our ambition of zero defects. This role reports to the Senior Director, Operational ExcellenceKey ResponsibilitiesLead and develop Scanfil’s global quality management system (SMS) to ensure unified processes, compliance, and continuous improvement. SMS tool Admin and feature development with tool vendor.Drive strategic quality development initiatives, methods, and key performance metrics (KPIs) across all factories. Scanfil Continuous Improvement (SCI) tool Admin and feature development with the tool vendor.Ensure compliance with medical device regulations (EU MDR, IVDR, US FDA 21 CFR Parts 820 and 11) and oversee related audits, inspections and certifications.Act as the Key Concept Owner for Scanfil’s Global Medical System certification and development projects.Provide leadership, guidance, and hands-on support to factory quality teams to enhance local quality performance.Manage and coordinate governance activities ensuring adherence to relevant standards and legal requirements.Foster a culture of excellence, knowledge sharing, and cross-functional collaboration.Qualifications & ExperienceMinimum 5 years of experience in quality, process development, or operations within an international manufacturing environment.Deep understanding of QMS models, ISO standards, and regulatory frameworks.Hands-on experience of Medical standards and regulations at EMS or Product owner manufacturing companies. Experience of Defence standards at manufacturing is an advantage.Experience working with statistical tools and proficient in Microsoft Office applications (Excel, Word, PowerPoint, Access), with additional knowledge of working with databases.Strong analytical skills with the ability to interpret data, assess risks, and support decision-making in medical systems and quality contexts.Proven track record of driving quality improvements and compliance in complex, multi-site organizations at matrix mode.Strong communication and stakeholder management skills with the ability to engage at all organizational levels.Proven track record of driving tool development and integration with external SW/IT vendorsFluent in English, both written and spoken; other languages are a plus.Business-oriented mindset with strategic thinking and operational focus.Personal QualitiesSystematic and organized with a strong quality focus.Team playerStrategic and change-oriented, with an ability to lead cross-cultural teams.Confident communicator capable of influencing both internal and external stakeholders.Results-driven and committed to operational excellence and continuous improvement.Thrives in a fast-paced environment by skillfully balancing short-term demands with long-term planning, making independent prioritization decisions to drive results.We offerA challenging and rewarding role in a global, high-performing organization, where you’ll have the chance to shape Scanfil’s quality strategy and medical systems for the future. You’ll join a company with 11 factories across Europe, APAC, and North America, employing around 4,000 people and achieving a turnover of EUR 780 million in 2024.If you are ready to take the lead in building a globally aligned, quality-driven organization — apply now and let’s build the future of excellence together.For more information, please contact Vesa Weiste, Senior Director, Operational Excellence (vesa.weiste@scanfil.com), or Malgorzata Klimkowska, Global HR Director (malgorzata.klimkowska@scanfil.com).Location: Scanfil offices or factories: Finland (Vantaa, Sievi, Oulu), Sweden (Stockholm, Åtvidaberg, Malmö), Poland (Sieradz, Myslowice), Germany (Wutha), Estonia (Pärnu).