Sanner Group

Quality Manager – Operations

Sanner Group

full-time

Posted on:

Location Type: Hybrid

Location: Bensheim • Germany

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About the role

  • Ensure compliance with quality standards (ISO 13485, GMP, medical device regulations) in collaboration with Operations
  • Manage deviation, CAPA and complaint processes, including root cause analysis and effectiveness checks
  • Conduct and support internal audits and assist with external audits and inspections
  • Approve serial line releases in coordination with Quality & Regulatory
  • Implement production-relevant changes as part of change control management
  • Provide technical guidance and coaching to the "Quality on the Shopfloor" team
  • Plan, organize and deliver training on quality topics for production staff
  • Actively contribute to new projects and continuous process optimization

Requirements

  • Successfully completed technical or scientific degree or equivalent vocational training with several years of professional experience
  • Several years of hands-on experience in quality management/operations, ideally in the medical device or pharmaceutical industry or primary packaging production
  • Solid knowledge of relevant standards and regulations (ISO 13485, MDR/IVDR awareness, GMP)
  • Practical experience with CAPA, FMEA and root cause analysis methods, as well as change control
  • Hands-on experience leading and motivating cross-functional teams
  • Analytical thinking and experience with quality metrics
  • Very good German and good English skills, both written and spoken
Benefits
  • 30 days of vacation
  • Flexible working hours
  • Option for remote/mobile work
  • Diverse health and wellness offerings
  • Bike leasing
Applicant Tracking System Keywords

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

Hard Skills & Tools
ISO 13485GMPMDRIVDRCAPAFMEAroot cause analysischange controlquality metricsquality management
Soft Skills
analytical thinkingleadershipteam motivationcoachingtraining deliverycollaborationorganizational skillscommunication skills