Auf einen Blick
- Aufgaben: Leite das Qualitätsmanagementsystem und sorge für die Einhaltung von ISO-Standards in Europa.
- Unternehmen: Innovatives Unternehmen im Bereich Spezialdiagnostik mit einem starken Fokus auf Qualität.
- Vorteile: Flexibles Arbeiten, wettbewerbsfähiges Gehalt und die Möglichkeit zur beruflichen Weiterentwicklung.
- Weitere Informationen: Arbeiten in einem dynamischen Team mit internationalen Kontakten und Entwicklungsmöglichkeiten.
- Warum dieser Job: Gestalte die Qualitätssicherung und beeinflusse wichtige Projekte in der Gesundheitsbranche.
- Qualifikationen: Erfahrung im Qualitätsmanagement und Kenntnisse der ISO 9001/13485 Standards erforderlich.
Das prognostizierte Gehalt liegt zwischen 63000 - 77000 € pro Jahr.
- Quality & Regulatory Management Representative
- Position Summary
As part of the European Quality & Regulatory team, this role supports commercial activities within the Specialty Diagnostics Group (SDG), including sales and marketing, distribution, importation, warehousing, customer service, and field service operations.
The position ensures that the TFD Quality Management System remains effective, compliant with ISO 9001 and ISO 13485 standards, and aligned with applicable regulatory requirements across assigned European regions.
Primary countries supported
France, Belgium, Luxembourg, Italy, Spain, and Portugal.
Key Responsibilities
- Ensure the effective implementation, monitoring, and maintenance of the TFD Quality Management System (QMS) across assigned European regions.
- Maintain compliance with ISO 9001 and ISO 13485 certification requirements and support QMS deployment activities.
- Plan and execute regional Management Reviews and monitor overall QMS performance.
- Manage quality processes, including NCRs, CAPAs, and audit observations, ensuring timely resolution.
- Lead and coordinate internal and external audit activities, including preparation, execution, and follow-up.
- Collaborate with local site teams, business partners, customers, suppliers, distributors, and regulatory stakeholders on quality and compliance topics.
- Support complaint management processes and ensure appropriate follow-up within the region.
- Drive Extended Producer Responsibility (EPR) activities and support product legislative compliance initiatives (e. g., WEEE, battery directive, PPWR).
- Support quality training activities and mentor employees involved in quality processes.
- Partner with Thermo Fisher Scientific teams to drive continuous improvement and harmonization of quality practices.
Requirements & Qualifications
- Degree in Engineering, Biological Sciences, Chemistry, Biochemistry, or equivalent preferred.
- Proven experience working with Quality Management Systems in regulated environments.
- Strong knowledge of ISO 9001 and ISO 13485 standards.
- Experience with Gx P and quality compliance requirements.
- Confirmed internal auditing experience (ISO 9001 required; ISO 13485 preferred).
- Experience with product legislative compliance (PLC) is a plus.
- Strong communication and stakeholder management skills, with the ability to influence teams across different functions and countries.
- Ability to work independently and manage priorities effectively in a remote environment.
- Customer-focused mindset with an understanding of commercial processes.
- Fluent professional communication skills in French and English (written and spoken).
- Willingness to travel occasionally within Europe for audits and site visits.
Start Date
ASAP
Duration
10 months
Location
- Remote (with occasional travel within Europe)
- #J-18808-Ljbffr
Remote QMS & Regulatory Lead - Europe (ISO 9001/13485) Arbeitgeber: K-Recruiting Life Sciences
Als Arbeitgeber bieten wir eine dynamische und unterstützende Arbeitsumgebung, in der Teamarbeit und persönliche Entwicklung großgeschrieben werden. Mit einem attraktiven Weiterbildungsbudget, regelmäßigen Teamevents und einem modernen Büro am Englischen Garten in München schaffen wir ein Umfeld, das sowohl berufliche als auch persönliche Ziele fördert. Unsere Unternehmenskultur ist geprägt von Offenheit, Innovation und einem starken Fokus auf die Optimierung unserer Prozesse, was dir die Möglichkeit gibt, aktiv zur Weiterentwicklung unseres Finance-Bereichs beizutragen.
Kontaktdaten:
K-Recruiting Life Sciences Recruiting-Team
