




**Company Description** Location: Remote within Europe We are SGS – the world's leading 5\-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. **Job Description** We are seeking a knowledgeable and driven **Technical Manager, QMS** 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\. **Your Mission** As Technical Team Manager, you will: * Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical). * Establish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities. * Provide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices. * Support operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services. * Work closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly. **Key Responsibilities** * Design and manage training programs for QMS Auditors, globally. * Approve Level 1 audits and witness audits for auditor qualification and requalification. * Contribute to recruitment, onboarding, and approval of new personnel. * Develop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance. * Ensure competence, compliance, and operational efficiency across assessment teams. * Provide technical support across SGS NB 1639 activities and contribute to business development **Qualifications** * **Education:** Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field. * **Experience:** + 10\+ years in the medical device industry, including at least 5 years in R\&D or manufacturing roles. + Minimum 4 years working within a Notified Body. + Minimum 2 years leadership experience + Prior qualification as a Lead Auditor under MDR and/or IVDR. + Strong background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.). * **Skills:** + Deep technical knowledge of non\-clinical aspects of medical device conformity assessment. + Proven ability to develop and deliver effective training. + Strong understanding of EU regulatory frameworks and best practice guidance. + Excellent stakeholder engagement, problem\-solving, and communication skills **Additional Information** **Why SGS?** * Opportunity to work with a global leader in inspection, verification, testing, and certification. * Collaborative and inclusive work environment. * Competitive salary and benefits package. * Opportunities for professional growth and development. Join 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.


