Process & Medical Device Risk Manager

Process & Medical Device Risk Manager (m/f/d) in Rostock, Berlin or Home Office

Welcome to CENTOGENE!

CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
How do we do this? By bringing together more than 400 individuals from 50 different countries at our HQ in Rostock, Germany, as well as our offices in Berlin, Belgrade, and laboratory facilities in Cambridge, MA. Our employees are medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more – and are all passionate about supporting our company vision : A world healed of all rare and neurodegenerative diseases.
Does this sound like you? If it does, we’d love to hear from you!

Your tasks will be:

For our laboratory processes and IVD medical device, your expertise is needed to further develop the risk-based approach for all processes and products that is triggered by an effective Business continuity planning.
# Manage the risk management system for our in vitro diagnostic medical devices, laboratory processes and business continuity by profound analysis of process parameters and in-process controls.
# Maintain the risk management files of our in vitro diagnostic medical devices in accordance with ISO 14971.
# Coordinate the system for nonconformities, CAPAs and complaints handling with regard to risk management.
# Based on the identified risks and their mitigation provide input to further develop the quality management system according to ISO 13485, ISO 15189, 21 CFR 820 and IVDR (EU) 2017/746 regulation
# Conduct internal and supplier audits and assist in addressing and documenting findings.

You have the following skills and qualifications:

# Completed scientific or technical degree or comparable training
# Initial professional experience in the field of managing risks according to ISO 14971.
# Experience as internal process auditor is a benefit
# Knowledge of further risk management methods (i.e. ISO 31000, FMEA, FTA) or Six-Sigma is a benefit
# Sound knowledge of quality management systems for medical devices and laboratories, is preferred.
# Structured, responsible, and solution-oriented work approach.
# Business fluent English skills, both written and spoken, combined with high communication and teamwork skills.

Those advantages are waiting for you at CENTOGENE:

# Talents are individually supported by internal and external trainings
# An international career in a multicultural environment
# Regular company events form us as one team
# In house yoga classes, back exercises and a fitness area are available for free
# Bike leasing or job tickets allow an environmentally friendly and reasonable travel to work
# In case of language barriers we offer German and English classes as well as support in finding accommodation to help you get going
# Precaution and financial protection guaranteed by company pension scheme
Applications from severely disabled people with appropriate suitability are explicitly welcome. Severely disabled applicants and equivalent status are given preferential consideration in the event of equal qualification.
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Scope of activities

Process planning and quality assurance

Career level

Professional

Locations

Am Strande 7, 18055 Rostock, Germany
Alboinstraße 42, 12103 Berlin, Germany
Home office

Employment type

Full time

Make CENTOGENE your next career move

For those who embark on a career with CENTOGENE, they’ll enjoy an exciting, dynamic, entrepreneurial and extremely fast-paced environment. Working alongside dedicated colleagues, CENTOGENE employees enjoy other benefits including upskilling from a dedicated training department, yoga classes, company-sponsored bicycle leasing, German language classes, and new state-of-the-art premises conveniently located featuring roof terraces and an in-house fitness center. For employees new to Rostock we’ll also support on finding local housing.

Who we are

CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including its epidemiological and clinical heterogeneity and our innovative biomarkers.
As one of the largest rare disease companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families.