Remote Medical Device QMS Audit & Training Lead

SGS; Lisboa; Remote; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary and benefits package

Opportunities for professional growth and development

Collaborative and inclusive work environment

Job summary

A global leader in testing and certification is seeking a Medical Device QMS Audit Manager in Lisbon, Portugal. This role involves leading the training and qualification processes for QMS Auditors and ensuring regulatory compliance. Candidates should have over 10 years of experience in the medical device industry, including 5 years in R&D or manufacturing, along with strong skills in QMS auditing. This position offers competitive salary and opportunities for professional growth.

Qualifications

• 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.).

Responsibilities

• Lead the development and delivery of training and qualification frameworks for technical staff.
• Approve Level 1 audits and witness audits for auditor qualification.
• Contribute to recruitment, onboarding, and approval of new personnel.
• Ensure competence, compliance, and operational efficiency across assessment teams.

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

Education

Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field

Job description

A global leader in testing and certification is seeking a Medical Device QMS Audit Manager in Lisbon, Portugal. This role involves leading the training and qualification processes for QMS Auditors and ensuring regulatory compliance. Candidates should have over 10 years of experience in the medical device industry, including 5 years in R&D or manufacturing, along with strong skills in QMS auditing. This position offers competitive salary and opportunities for professional growth.