Job Description
Lifecare Germany GmbH, part of the Lifecare Group, is a clinical-stage medical sensor company developing advanced technologies for the sensing and monitoring of various body analytes. The German entity in Mainz is responsible for key development tasks including sensor design, chemistry validation, system evaluation and data analysis from both laboratory and patient studies. In addition to R&D, our laboratory provides commercial services for the pharmaceutical and biotechnology industries, supporting clinical research, testing and approval processes for drugs and medical devices, as well as general laboratory services for medical institutions. In 2023, we achieved ISO 9001 and ISO 13485 certification, underscoring our commitment to quality and regulatory standards.
To strengthen our team, we are looking for an experiences resource for our Quality Management Department in Mainz to fill the role as
Quality Management Specialist (full-time position).
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Supporting the development, implementation, and maintenance of the quality management system in accordance with ISO 9001 and ISO 13485 standards
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Identifying opportunities for process improvement within the company to increase efficiency, reduce errors, and optimize quality
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Supporting internal and external audits to evaluate the effectiveness of the OMS, identify opportunities for improvement, and ensure compliance with established standards
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Assisting in the creation and review of standard operating procedures (SOPs}, special work instructions, and other controlled documents
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Collaborating with cross-functional teams to ensure regulatory compliance
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Support in the development and implementation of necessary corrective and preventive actions (CAPAs) and review of their effectiveness in daily work
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Monitoring the implementation of process descriptions that influence the quality of the services provided
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Participating in all accreditation processes of Lifecare Germany GmbH
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Participating in and conducting communication with authorities, institutes, and similar institutions
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Ensuring the correct maintenance of quality records and compliance with documentation procedures, as well as supporting the training of employees in quality management practices
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Reporting fundamental changes to process flows and serious deficiencies in the QM system to management
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Collaborating in the design and operation of cross-company QM systems for the Lifecare Group and, if necessary, assuming responsibility for sub-areas of the systems
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Master's degree in biology, chemistry, physics, engineering, or a related field
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At least 6 years of experience in quality management with a focus on the development and implementation of OMS
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Expertise in ISO 13485 for medical devices is required, as is experience working in the medical and development fields
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Knowledge of legal regulations and requirements, such as ISO 9001, ISO 13485, IVDR, and MOR
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Extensive experience with OMS software and tools for document management and compliance
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Excellent written and verbal communication skills in English and German, combined with strong interpersonal abilities
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Ability to manage multiple priorities and work in a fast-paced environment
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Permanent employment contract (after successful completion of probationary period)
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Excellent and collaborative working atmosphere
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Developable position with competitive remuneration
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Various social benefits