CAPA Manager (EMEA) / CAPA Lead (m/f/d)

Stellenbeschreibung:

CAPA Manager (EMEA) / CAPA Lead (m/f/d)

Olympus Europa SE & Co. KG (OEKG) – Chief Quality Officer

Your Responsibilities

  • Leading and moderating technical and monthly CAPA board meetings at site and multi-site levels
  • Role as CAPA approver with responsibility for quality, completeness, and sustainability of CAPA content
  • Coaching, mentoring, and developing CAPA teams, investigators, and approvers
  • Conducting CAPA process and system training (on-site or virtually)
  • Monitoring CAPA performance, timelines, and KPIs
  • Subject Matter Expert (SME) for CAPA in quality management reviews, audits, inspections, and data analyses
  • Moderating cross-functional root cause analysis sessions
  • Collaborating with sites and the Global CAPA Center of Excellence to identify and address systemic or recurring issues
  • Ensuring consistent CAPA implementation and timely completion

Your qualification

  • A completed university degree, preferably in engineering, natural sciences, or a related field
  • Extensive experience in quality and a comprehensive understanding of the CAPA lifecycle (Issue Identification, Root Cause Analysis, Action Planning, Implementation, Effectiveness Check)
  • Proficiency in RCA methods (e.g., 5 Whys, Ishikawa/Fishbone, structured problem-solving)
  • Experience in moderation of cross‑functional RCA workshops
  • In-depth knowledge of relevant regulations and standards (e.g., FDA 21 CFR 210/211/820, ISO 9001 / ISO 13485)
  • Experience in audit and inspection preparation as well as defending CAPAs
  • Excellent communication- and cross‑functional collaboration skills

Your benefits

  • Flexible working hours, remote work possible (up to 60%)
  • 30 days of holidays per year
  • Modern office and an inspiring working environment
  • Employee restaurant with live cooking and healthy food (subsidized)
  • Public transport ticket (100 % subsidized) or free parking space
  • Company sport groups and an in‑house company gym
  • Employee Assistance Program to support your health, mental and emotional well‑being
  • A comprehensive company pension scheme
  • Company medical officer and vaccination offers
  • Childcare through our ‘Buttje&Deern’ partner
  • Company car, also for private use (for field staff only)
  • Bike leasing

About Olympus

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best‑in‑class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .

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Stelleninformationen

  • Veröffentlichungsdatum:

    26 Apr 2026
  • Standort:

    Hamburg
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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