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Open nowPosted yesterday

QA Compliance Manager | 80 - 100%

Ypsomed AG

Where
Solothurn, SO, Switzerland
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Your applicationOpen nowQA Compliance Manager | 80 - 100%Ypsomed AG · Solothurn, SO, Switzerland

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Ypsomed AG's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

13.6% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.3%1 day
  2. 4.7%3 days
  3. 13.6%7 days
  4. 21.9%14 days
  5. 36.9%30 days
  6. 59.0%60 days
This job: posted yesterday

The posting

Bei Ypsomed gestalten wir gemeinsam die Zukunft der Medizintechnik - mit dem Ziel, die Lebensqualität von Menschen mit chronischen Krankheiten nachhaltig zu verbessern. Wir fördern eine offene Unternehmenskultur, in der Vielfalt geschätzt wird und neue Perspektiven willkommen sind. Unsere Mitarbeitenden übernehmen Verantwortung, arbeiten interdisziplinär und entwickeln innovative Lösungen mit echtem gesellschaftlichem Mehrwert.

Als QA Compliance Manager stellst du innerhalb des Teams sicher, dass die vom Headquarter definierten Qualitätsanforderungen global umgesetzt, wirksam überwacht und kontinuierlich verbessert werden. Dein Schwerpunkt liegt auf datenbasiertem Trending, Root Cause Analysen, NC/CAPA, Change Control sowie der Befähigung der Mitarbeitenden durch Training und Coaching.

QA Compliance Manager | 80 - 100% #

Ref-Nr. 8256

Arbeitsort:

Solothurn

| Hybrid

Deine Hauptaufgaben ###

  • QA-Ansprechperson für ein definiertes Produkt; Unterstützung und Koordination standardisierter Aufgaben im Design- und Prozess-Transfer zwischen Business Area/Design und Operations an festgelegten Produktionsstandorten
  • Leitung und Management von NC/CAPA, Changes, Lessons Learnt, Risiken und Audits (Produkt und Prozess) und deren KPIs im Verantwortungsbereich - standortübergreifend und in Abstimmung mit den Stakeholdern
  • Support bei Schulung & Coaching von Mitarbeitenden zu NC/CAPA, RCA, Trending und risikobasierter Entscheidungsfindung
  • Teilnahme bei Behörden- und Kundenaudits sowie Bearbeitung von Audit-Findings
  • Proaktive Verbesserung der Produkt- und Prozessperformance durch Analyse, Priorisierung von Massnahmen und nachhaltiger Wirksamkeitskontrolle

Dein Profil ###

  • Abgeschlossenes technisches oder naturwissenschaftliches Studium (FH/Uni/HF) sowie mind. 5 Jahre Erfahrung in QA Compliance/Quality Systems im MedTech Umfeld (idealerweise im sterilen Umfeld für Injection-Devices)
  • Sehr gute Kenntnisse in ISO 13485 sowie praktische Erfahrungen mit MDR und FDA QMSR / 21 CFR 820
  • Nachweisbare Erfahrung in NC/CAPA, RCA-Methoden und datenbasiertem Trending mit Excel und Power BI
  • Lean / Lean Six Sigma (Green/Black Belt), Statistik/SPC sowie Ausbildung im Bereich interne Audits nach ISO 13485 von Vorteil
  • Hohe Tool-Affinität (z. B. S4/HANA, Quality-Tools wie TrackWise, Jira, Office, Excel)
  • Sehr gute Deutsch- (C1) sowie gute Englisch-Kenntnisse (B2) in Wort und Schrift

Posting text belongs to the employer. Removal requests: contact us.

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