TASKS
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Lead and manage the Quality Engineering team, plan workloads, capacity and priorities, and ensure your team members have the necessary qualifications and opportunities for professional development.
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Maintain and continuously improve our quality management system. Working with Regulatory Affairs, translate ISO 13485 and applicable regulatory requirements into our processes, close compliance gaps and support consistent quality standards across sites.
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Develop and update SOPs, process descriptions and work instructions, and coordinate their approval, associated training and timely implementation. You will also be responsible for document control, QMS change management and the administration of Dot Compliance.
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Plan and manage the audit programme, conduct internal and supplier audits, and support customer and certification audits. Systematically assess findings and follow up on associated actions to ensure timely and effective closure.
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Lead the CAPA process and ensure systematic root cause analyses and effectiveness checks. Manage deviations and supplier corrective action requests (SCARs) using a structured approach, working with the responsible functions to follow up on root causes and actions.
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Analyse QMS performance indicators, identify trends and areas requiring action, and prepare the management review. You will also lead quality improvement projects and train employees in QMS processes and quality methods.
PROFILE
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A university degree, preferably in engineering, natural sciences or a comparable discipline.
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At least five years of professional experience in quality, including hands-on responsibility for QMS, audits and CAPA.
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Experience in technical team leadership or project leadership. Previous people management experience and further training in leadership, quality management or process improvement are an advantage.
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A sound working knowledge of ISO 13485 and proficiency in audit planning, CAPA, root cause analysis, document control and change management. An internal auditor qualification is desirable.
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Familiarity with quality management systems, performance indicators, data analysis and MS Office. Knowledge of Dot Compliance, Epicor and statistical improvement methods is an advantage.
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Very good German and English language skills. Experience in the medical device industry and collaboration across sites is desirable.
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A clear and consistent leadership style, the ability to adapt your communication to different audiences, and a structured, independent and analytical approach to work. Assertiveness, conflict resolution skills, teamwork, integrity and a commitment to continuous improvement complete your profile.