Quality Assurance Specialist (m/f/d)

Einsatzort: Berlin

Epigenomics AG is a molecular diagnostics company that develops and markets innovative products for the early detection and diagnosis of cancer. These products allow physicians to diagnose cancer earlier and more accurately, enabling better therapeutic outcomes for patients. Epigenomics is an international company with offices in Berlin and the USA.

To strengthen our Quality Team in Berlin, we are looking for a

Quality Assurance Specialist (m/f/d)

Tasks and Responsibilities:

  • Maintenance and continued development of the quality system compliant with FDA's Quality System Regulation (21 CFR Part 820) and ISO 13485
  • Assist cross-functional partners (e.g. development, manufacturing, commercial, etc.) in quality assurance activities including projects and day-to-day operations
  • Support administration of the document control and training programs, assign document numbers, route procedures for review and approval, and track / organize employee training records
  • Support product acceptance activities per internal standard operating procedures and policies
  • Maintain and monitor quality record logs for equipment, deviations, CAPA, complaints, audits, etc. Provide maintenance support to these systems as directed by supervisor
  • Assist in identifying, analyzing, and interpreting quality metrics to measure the effectiveness of the quality system
  • Prepare agendas and capture meeting minutes for designated quality system meetings
  • Organize and track action items as required
  • Support quality management in supplier, internal, and external audits as needed
  • Provide suggestions for continuous improvement of company products and processes

Minimal Skills & Qualifications:

  • Academic degree or equivalent work-related experience in a science related field
  • Min. 1 year previous experience in a quality function, or related work experience in collaborating with a quality team, or quality assurance related academic experience
  • Experience in an industry regulated by FDA, or knowledge of the ISO 13485 Standard preferred. Experience with In Vitro Diagnostics (IVDs) a plus
  • Ability to manage and prioritize multiple daily and weekly tasks as directed by supervisor
  • Strong organizational skills
  • Excellent communication skills, professional and confident when dealing with internal partners
  • Team spirit and pragmatic, goal-oriented working style
  • "Hand's on" mentality and absolute willingness to work in a fast-paced environment
  • Demonstrated ability to learn new information quickly
  • Fluent in German and English

We offer:

  • A forward-looking company with a corporate culture based on flat hierarchies, openness and fairness
  • A modern and international working environment
  • Space for independent work
  • Personal development through training programs
  • Flexible working time models and performance-based compensation

Are you reliable, flexible and like working in a team? Then we would like to get to know you.

Further information regarding this position can be obtained from Joel Centeno, Senior Vice President Regulatory & Quality: joel.centeno@epigenomics.com

If interested, please email your complete application with salary expectations and possible start date to: