Technical Manager QMS

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 MissionAs 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 InformationWhy 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.