Head of Quality Assurance MFD MedDev - CZ Site

Head of Quality Assurance (m/f/d) - Medical Devices | Czech Republic Our client is an established international medical device manufacturing company specializing in the development and production of innovative healthcare products. To support continued growth and ensure the highest quality standards, we are seeking an experienced quality leader for a manufacturing site in the Czech Republic. Key ResponsibilitiesLead and develop the site Quality Assurance team, serving as the primary quality escalation point for operations and cross-functional stakeholdersEnsure the effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including CAPA, nonconformances, complaints, change control, document control, and risk managementDrive management review processes and proactively identify and escalate quality risks and performance trendsMaintain compliance with ISO 13485, EU MDR, and other applicable regulatory requirements.Lead preparations for notified body audits, regulatory inspections, and customer audits, acting as the key point of contact during inspectionsEnsure timely and effective resolution of audit findings and inspection observationsPartner closely with Manufacturing and Operations teams to support production while ensuring full compliance with quality standardsLead deviation investigations, product impact assessments, and product release decisionsDrive root cause investigations, CAPA effectiveness programs, and continuous improvement initiatives using data-driven methodologies Required QualificationsDegree in Engineering, Life Sciences, Quality Management, or a related technical disciplineMinimum 5 years of progressive experience in Quality Assurance within the medical device industry or another highly regulated manufacturing environmentIdeally, previous experience in a senior or leadership-level Quality Assurance role and/or working experience in international, multi-site, or matrix organizationsStrong knowledge of ISO 13485 and EU MDR; familiarity with FDA regulations is an advantageCertification or experience in Lean, Six Sigma, or other continuous improvement methodologiesDemonstrated experience leading audits, inspections, and regulatory interactionsFluent Czech and English language skills; German is considered an asset Interested in learning more about this opportunity and the organization? Please feel free to get in touch: Yana LeidigRecruitment Consultant | Medical DevicesPermanent Division | QM, QC, QA & Notified Bodies. SThree_Germany is acting as an Employment Agency in relation to this vacancy.