Quality Assurance Senior Engineer NCR / Capa (m/w/d)

About Merz Aesthetics

Merz Aesthetics ist ein unabhängiges, international tätiges Unternehmen im Bereich der ästhetischen Medizin. Unser umfassendes Produktportfolio gehört seit Jahren zu den qualitativ hochwertigsten innerhalb ihrer Kategorie und wird von Health Care Professionals weltweit geschätzt. Wir von Merz Aesthetics sind Teil der Merz-Gruppe und haben unsere EMEA-Zentrale in Frankfurt am Main. Unser globales Headquarter befindet sich in Raleigh, North Carolina, USA. Tagtäglich setzen wir uns mit mehr als 3.000 Mitarbeiter*innen in 26 Ländern dafür ein, die Schönheit der Haut wiederherzustellen und zu erhalten.

An unserem Standort im Biopharmapark Dessau- Roßlau ist unser eigenständiges Produktionswerk auf Erfolgskurs. Wir befinden uns in einer gesunden Wachstumsphase und bieten einen sicheren Arbeitsplatz, an dem du deine Erfahrung und Ideen mit großer Eigenverantwortung einbringen kannst.

Möchtest Du Teil unserer Erfolgsgeschichte werden? Dann starte bei Merz Aesthetics!

Your Tasks

• Audit - Preparation and support for internal (self-inspections) and external audits/inspections (e.g., TÜV, authorities)
• Acting as an internal auditor - Ensuring full compliance with occupational health and environmental protection regulations in production
• Review of completed device history records documentation
• Creation of quality documents
• Maintenance of controlled copies and backups, maintenance of the archive within the scope of all QA-related activities
• Archiving and digitization of documents Interface
• Acting as a liaison between quality and operational departments
• Support in identifying and processing actual or potential deviations or CAPAs related to products, processes, and quality management systems and corresponding application of the deviation management procedure
• Management of the change control process
• Identification of improvement opportunities in processes and associated documentation, followed by proposing and implementing solutions
• Processing of complaints with regard to review and creation of reports

What convinces us

• Master's/Engineering degree in a biomedical/scientific/legal field
• Knowledge of European, American, Australian, and Canadian standards, laws, and guidelines
• At least 3 years of experience in quality assurance; ideally in the pharmaceutical or medical device industry (development, manufacturing)
• Sound knowledge of quality system management (21 CFR Part 820, ISO 13485, MDSAP)
• Knowledge in a GMP environment
• Ability to align business/commercial goals with the necessary details to define a compliant process
• Precise, clear, and customer-oriented communication of technical information, both verbally, in writing, and in person
• Organized way of working and ability to work independently under tight deadlines
• Proficient in Microsoft Office
• Fluent English and German, both written and spoken

What we offer you

People at the center: At Merz Aesthetics, you can expect an open work culture with flat hierarchies and short decision-making paths. You will collaborate with colleagues from all over the world. And if life takes an unexpected turn and you need help or advice, you can always rely on our various internal and external counseling services.

Family & Work: Our employees should be able to balance their private, family, and professional lives as best as possible. That's why you'll find company kindergartens at our locations, for example. In the EMEA region, we have been recognized as "Top Employer" and "Great Place to Work" for our excellent HR policies and work culture.

Balanced Work-Life-Harmony: Our time is precious, our daily rhythm individual. So that you can reconcile work and leisure in your own way, we rely on modern flexible working time models. We offer you flextime and trust-based working hours as well as mobile working. Our employees also benefit from generous holiday arrangements.

Further Training: Your personal and professional development is key to our success. That's why we conduct regular development discussions and offer a wide range of management and specialist training, soft skills courses, e-learning courses, language courses, and coaching.

Compensation: You can expect performance-based pay; we pay according to the collective agreement for the chemical industry (East).

If you want to learn more and we can apply to you, follow this link:

https://merz-aesthetics.de/