Aignostics

Quality Manager Specialist – CAPA, Change Management

Aignostics

full-time

Posted on:

Location Type: Hybrid

Location: Berlin • Germany

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About the role

  • Build Robust Quality Systems: Establish and maintain CAPA management systems in full compliance with ISO 13485
  • Design and oversee change management processes aligned with ISO 13485 and IEC 62304
  • Maintain comprehensive QM documentation including SOPs, work instructions, and quality records
  • Translate regulatory requirements (IVDR, ISO 13485, FDA QSR) into actionable QM system elements
  • Analyze quality and change data to identify trends, systemic issues, and improvement opportunities
  • Enable Cross-Functional Excellence: Partner with software engineers, data scientists, and product teams on root cause analysis and corrective measures
  • Coordinate and support internal and external audits (notified body, regulatory authorities)
  • Facilitate CAPA and change review meetings where diverse perspectives are heard and the best ideas win
  • Build collaborative relationships across all departments to embed quality thinking everywhere
  • Foster a Learning Culture: Develop and deliver training programs on CAPA management, change control, and quality processes
  • Share lessons learned from CAPAs and audits to drive organizational learning
  • Create a psychologically safe environment where quality concerns can be raised openly
  • Mentor team members and stakeholders in quality management principles

Requirements

  • Proven expertise in quality management systems, CAPA methodologies, and change control processes
  • Strong proficiency with root cause analysis tools (5 Whys, Fishbone diagrams, Fault Tree Analysis)
  • Solid understanding of ISO 13485, ISO 14971, IEC 62304, IVDR, and 21 CFR Part 820
  • Experience planning, conducting, and supporting internal and external audits
  • Excellent written and verbal communication skills in English
  • Ability to influence and collaborate effectively with diverse stakeholders at all levels.
Benefits
  • Competitive remuneration package in addition to perks and benefits
  • Expand your skills by benefitting from our Learning & Development yearly budget of 1,000€ (plus 2 L&D days), language classes and internal development programs
  • Mentoring program, where you'll learn from and mentor great experts
  • Flexible working hours and teleworking policy
  • Enjoy your well-deserved time off with 30 paid vacation days per year
  • We are family & pet friendly and support flexible parental leave options
  • Pick a subsidized membership of your choice among public transport, sports, and well-being
  • Enjoy our social gatherings, lunches, and off-site events for a fun and inclusive work environment
  • Optional company pension scheme
Applicant Tracking System Keywords

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

Hard Skills & Tools
quality management systemsCAPA methodologieschange control processesroot cause analysis5 WhysFishbone diagramsFault Tree AnalysisISO 13485IEC 62304IVDR
Soft Skills
communication skillscollaborationinfluencementoringfacilitationorganizational learningpsychological safetycross-functional teamworkproblem-solvingtraining development