Ph3Company Description /h3 pLocation: Remote within Europe /p pWe 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. /p h3Overview /h3 pWe are seeking a knowledgeable and driven bMedical Device QMS Audit Manager /b 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. /p h3Your Mission /h3 pAs Technical Team Manager, you will: /p ul liLead the development and delivery of training and qualification frameworks for technical staff (excluding clinical). /li liEstablish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities. /li liProvide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices. /li liSupport operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services. /li liWork closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly. /li /ul h3Key Responsibilities /h3 ul liDesign and manage training programs for QMS Auditors, globally. /li liApprove Level 1 audits and witness audits for auditor qualification and requalification. /li liContribute to recruitment, onboarding, and approval of new personnel. /li liDevelop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance. /li liEnsure competence, compliance, and operational efficiency across assessment teams. /li liProvide technical support across SGS NB 1639 activities and contribute to business development /li /ul h3Qualifications /h3 ul libEducation: /b Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field. /li libExperience: /b ul li10+ years in the medical device industry, including at least 5 years in RD or manufacturing roles. /li liMinimum 4 years working within a Notified Body. /li liMinimum 2 years leadership experience /li liPrior qualification as a Lead Auditor under MDR and/or IVDR. /li liStrong background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.). /li /ul /li libSkills: /b ul liDeep technical knowledge of non-clinical aspects of medical device conformity assessment. /li liProven ability to develop and deliver effective training. /li liStrong understanding of EU regulatory frameworks and best practice guidance. /li liExcellent stakeholder engagement, problem-solving, and communication skills /li /ul /li /ul h3Additional Information /h3 h3Why SGS? /h3 ul liOpportunity to work with a global leader in inspection, verification, testing, and certification. /li liCollaborative and inclusive work environment. /li liCompetitive salary and benefits package. /li liOpportunities for professional growth and development. /li /ul pJoin Us: At SGS, we are dedicated 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