stillingsbetegnelse: QA Engineer-RAD001056

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 MedTech – CAPA and audits – QA support to subs and distributors Do you want to use your skills to secure the quality of Radiometers products? Are you motivated by working in a global organization characterized by cross-functional cooperation and problem-solving? If you can answer yes to these questions, you could be the right candidate for an open position in QA Systems. The QA Systems team is responsible for: •Radiometer’s global quality management system and document handling system. •Hosting inspections from authorities and 3rd party audits. •Managing the internal/external audit program. •Process ownership of the CAPA process Lastly, we are involved in a number ofother tasks within the Radiometer RA/QA organization. We are looking for an experienced QA Engineer with a global mindset ready to take on different tasks and drive the tasks to completion. QA Systems has the process ownership of the CAPA process, and the process is managed by an experienced CAPA supervisor. Your primary assignment will be to drive Radiometer’s CAPA system working with the CAPA supervisor. This includes coordination of CAPAs within the Radiometer organization to secure CAPAs are completed on time and with the right quality. To do this you will use the right LEAN tools, perform user training, and engage with the organization. Furthermore, you will take ownership of driving Radiometer’s QA activities involving sales subsidiaries and distributors and secure continuous improvements. You will become a member of Radiometer’s audit team responsible for performing internal audits and external audits of suppliers globally. You will have excellent opportunity for further professional development as we have a lot of exciting projects in the pipe-line and opportunities for improvement going forward. The job Your responsibilities and tasks will include: •Responsibility for Radiometer’s CAPA system (with supervisor). •Responsibility for Radiometer’s QA activities related to sales subsidiaries and distributors. •Performing audits. •Ad hoc tasks, e.g. participation during inspections/3rd party audits. Estimated travel activity could be 5-10%of the time. 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: •Theoretical engineering/natural science background (Bachelor or Master degree). •QA experience from Medical Devices or Pharma business. •5+ years’ experience in QA disciplines: QMS, CAPA, Audit/Inspections, document handling systems. •Experience from an ISO certified company (ISO 9001/13485). •A formal education as auditor is an advantage, but not a requirement. •Language skills: fluent English is a requirement. Danish/Scandinavian will be an asset. •IT skills: experienced in using MS office (word/excel). Experience with document handling systems and/or workflow systems will be an advantage. You must be passionate and committed about what you do, as well as:

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

Arbejdsgiver telefonnummer: 38272829

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark