Medical Device QMS Audit Manager at SGS

Bucureşti, Bucharest, Romania -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Industry, QMS Auditing, Technical File Assessment, EU Regulatory Frameworks, Training Development, Stakeholder Engagement, Problem-Solving, Communication Skills

Industry

Professional Services

Description

Company Description Location: Remote within Europe We 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. Job Description We 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. 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.

Responsibilities

Lead and oversee the training, qualification, and compliance processes for QMS Auditors involved in medical device conformity assessments. Ensure the competence of technical personnel and the continued regulatory compliance of SGS Notified Body 1639.