PpWe are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,500 employees operate a network of 2,500 offices and laboratories, working together to enable a better, safer and more interconnected world. /ppLocation: Remote within Europe /ph3Job Description /h3pWe are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training, qualification, and compliance processes for QMS Auditors involved in our medical device conformity assessments. This non-clinical role plays a vital part in ensuring the competence of technical personnel and the continued regulatory compliance of SGS Notified Body 1639. /ph3Your Mission /h3pAs Technical Team Manager, you will: /pulliLead the development and delivery of training and qualification frameworks for technical staff (excluding clinical). /liliEstablish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities. /liliProvide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices. /liliSupport operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services. /liliWork closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly. /li /ulh3Key Responsibilities /h3ulliDesign and manage training programs for QMS Auditors, globally. /liliApprove Level 1 audits and witness audits for auditor qualification and requalification. /liliContribute to recruitment, onboarding, and approval of new personnel. /liliDevelop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance. /liliEnsure competence, compliance, and operational efficiency across assessment teams. /liliProvide technical support across SGS NB 1639 activities and contribute to business development. /li /ulh3Qualifications /h3ullibEducation: /b Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field. /lilibExperience: /bulli10+ years in the medical device industry, including at least 5 years in RD or manufacturing roles. /liliMinimum 4 years working within a Notified Body. /liliMinimum 2 years leadership experience. /liliPrior qualification as a Lead Auditor under MDR and/or IVDR. /liliStrong background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.). /li /ul /lilibSkills: /bulliDeep technical knowledge of non-clinical aspects of medical device conformity assessment. /liliProven ability to develop and deliver effective training. /liliStrong understanding of EU regulatory frameworks and best practice guidance. /liliExcellent stakeholder engagement, problem-solving, and communication skills. /li /ul /li /ulh3Additional Information /h3pWhy SGS? /pulliOpportunity to work with a global leader in inspection, verification, testing, and certification. /liliCollaborative and inclusive work environment. /liliCompetitive salary and benefits package. /liliOpportunities for professional growth and development. /li /ulpSGS is an equal opportunities employer and is committed to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfil your potential. /p /p #J-18808-Ljbffr