Arbejde QA Specialist-RAD000603 Hovedstaden RADIOMETER MEDICAL ApS - jobtilbud

software quality assurance testing services

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stillingsbetegnelse: QA Specialist-RAD000603

jobbeskrivelse:
Danaher Company Description Radiometer - Make an impact on life. The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2500 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than DKK 3 billion and is owned by US-based Danaher Corporation. Description Design Control and validation - System optimizing - Global alignment With reference to the Director, QA Engineering and Operations, you will join a team of highly skilled colleagues. QA Engineering is responsible for building quality into the new products during the development phase by ensuring Design Control and validation documentation is fulfilling regulatory and internal demands. In the QA Operations and QA Engineering departments, we are 16 people in total, and we cooperate with colleagues in RA, R&D, Marketing, Production, Production Quality and other departments across the entire organization. Also, you will work together with RA/QA colleagues at other Radiometer sites to ensure alignment and implementation of global procedures. The job To become successful, you be proactive as well as follow your tasks through to completion. Your responsibilities and tasks will include: •Participate in continuous development of systems to ensure compliance related to Design Control and validation. •Ensure compliance of Design Control documents to secure a more efficient 510 K approval. •Review of Design Control and validation documents. •Participate in R&D projects. •Participate in implementing a new change control system. Qualifications "Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success: •Preferably a Master degree in Engineering or Pharmacy. •Highly experienced within the following areas: ?Design Control documentation, including Risk Management ?Medical Device legislation (MDD, IVD) ?Process validation ?Software validation (knowledge of SW development an asset) •Danish and English at a professional level, oral and written. •Knowledge of statistical software preferred. Taking responsibility and being committed about what you do are essential strengths, as well as being: •Proactive, showing great initiative. •Systematic and well organized. •Persistent with focus on finalizing tasks within deadlines. •Team-oriented and flexible. Interviews will be held as soon as relevant candidates have been identified ...so please do not hesitate to apply. Start the application process by pressing "Apply" and follow the guidelines on our corporate career site. Upload your CV and other relevant documents. Please bring diplomas for face-to-face interviews. We are looking forward to receiving your application. We offer you A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits. For further information, please contact Director, QA Engineering and Operations,

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

Arbejdsgiver telefonnummer: 12345678

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

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