Metabolomic Diagnostics Ltd is a deep-tech company specialized in the development of novel biomarker-based diagnostic solutions for complex diseases. The company is developing novel and innovative tests to predict pregnancy related complications prior to their clinical manifestation. To further Metabolomic Diagnostics’ product development, we are hiring a Quality Coordinator will be responsible for all aspects of the company’s Quality Management System. Monitoring, evaluating, and administering internal processes the role ultimately will ensure effective and efficient management of the Quality Management System and compliance to the relevant Regulatory Requirements and International Standards.
Job Responsibilities for Quality Coordinator
- Management and maintenance of all aspects of the company’s Quality Management System, ensuring that processes needed for the QMS are established, implemented, and maintained. Including implementation of documents, training, CAPAS, Change Controls etc to ensure meeting all requirements of the relevant standard.
- Ensure all Quality system records are accurate, up to date and in accordance with company needs to fulfil mission statement and ambitions.
- Identifying areas for quality improvement and delivering improvement.
- Support all staff to ensure Quality is effective and efficient in the workplace.
- Collaborate with laboratory personnel on the compilation, drafting and updating of SOPs’ relevant to the daily laboratory and biorepository operations.
- Support Validation processes within the company, including equipment & software, as well as validation of new product performance or new laboratory processes, in line with the product development goals of the company.
- Leading the company through audits.
- Staying up to date with latest quality and regulatory related developments.
- Support, advise and collaborate with the R&D manager to ensure the appropriate documentation framework is applied for the recording of R&D activities.
- A Bachelor’s degree in a scientific discipline with >2 years experience in a Quality related role.
- Skills and knowledge about Quality Management and Regulations (ISO9001 and/or ISO13485). Internal auditing experience is desirable.
- Experiences that demonstrate an understanding of the level of detail required for effective and efficient management of the quality system.
- Being able to plan and organize using your time efficiently to complete work assignments on time.
- Strong communication and organisational skills.
- Taking responsibility and being conscientious towards your tasks.
- Participating in discussions with an open and constructive attitude.
- Being able to work in an environment that is likely to undergo frequent changes.
- Taking initiative and being prepared to take full ownership of a number of company processes.
Working with Metabolomic Diagnostics
The position presents a unique experience to be part of a dynamic, international team focused on delivering novel diagnostic solutions for mothers-to-be. As a member of the team you will contribute to bringing product to market from Conception to Validation. Being part of an early stage company presents a great opportunity to rapidly expand one’s experience.
Metabolomic Diagnostics is based in Cork, Ireland and offer a competitive salary package.
Contact: Interested applicants should contact firstname.lastname@example.org