DQS

Product File Reviewer – Medical Device Auditor

DQS

full-time

Posted on:

Location Type: Hybrid

Location: Bad Vilbel • 🇩🇪 Germany

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Job Level

Mid-LevelSenior

About the role

  • Evaluation of technical documentation (TD review) of medical devices under the MDR
  • Conducting audits in accordance with the MDR, ISO 13485, and, if applicable, MDSAP
  • Assessment of changes to products and quality management systems, SSCPs, PSURs, and vigilance as part of continuous monitoring
  • Preparation of audit programs and sampling plans, allocation of resources, verification of applications, classification, coding, etc.
  • Participation in conformity assessment procedures, particularly for complex or novel medical devices
  • Technical exchange with internal and external experts (e.g., clinical experts, risk assessors)
  • Support for regulatory authority inquiries and, if required, participation in inspections by ZLG, DAkkS, and SCC
  • Support of internal improvement measures

Requirements

  • Degree in a relevant field (e.g., medical technology, biomedical sciences, engineering, natural sciences)
  • Several years of professional experience (>4 years) in the development, manufacturing, testing, or quality assurance of active or non-active medical devices
  • Ideally several years (>10 years) of professional experience as an auditor and/or product assessor at a Notified Body for the MDR (EU) 2017/745
  • In-depth knowledge of the MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP documentation, as well as other regulatory requirements, MDCG guidance, and product standards
  • Recognized and demonstrable qualifications as a Lead Auditor for MDR and ISO 13485, and ideally MDSAP
  • Fluent German and English, both written and spoken
Benefits
  • Hybrid working: office and remote
  • Flexible working hours
  • Job ticket for public transport
  • Company bike (JobRad)
  • 30 days annual leave
  • Employee savings plan (Vermögenswirksame Leistungen)
  • Canteen and lounge

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
MDRISO 13485ISO 14971ISO 10993IEC 62304IEC 62366-1IEC 60601ISO 14155MDSAPquality management systems
Soft skills
communicationtechnical exchangecollaborationauditingassessmentproblem-solvingresource allocationcontinuous monitoringregulatory supportinspections participation
Certifications
Lead Auditor for MDRLead Auditor for ISO 13485MDSAP certification