id: NDg3Mjk1MiA3

reference: 4872952

documentId: 4872952

connectionPointId: 7

lastModificationDate: 1536055086640

stillingsbetegnelse:
Senior QA Design Control Specialist, Sampler and Sterilization

jobbeskrivelse:

The QA Engineering team has a significant role in ensuring safe, reliable and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training and communicating towards the best results with partners in R&D. 

The position is located in Denmark and is part of a team of 6 highly skilled engineers supporting design control for Blood Gas, Transcutaneous monitoring and sterilized sampler products. 
The position is acting as a Senior QA specialist within specific projects in sampler product development with special responsibility in EtO sterilization processes. 

Responsibility
• Sterilization specialist for outsourced EtO sterilization at contract manufacturers.

• Team management for sterilization team including QA colleague located at the Polish site.

• Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.

• Represent Quality Assurance in design and development projects and on cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation.

• Collaborating closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.

• Take part in the Quality assurance activities as an active member of relevant project teams. 

• Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations.

• Participating in quality training activities.

• Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.

Contribute, grow and develop

Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.

Application deadline

Application deadline is Monday 24 September 2018, but we will interview as soon as we identify relevant candidates. Please start the application process as soon as possible by pressing "Apply Online". Please attach your CV and other relevant documents. We look forward to receiving your application.

For further information, please contact Manager, QA Engineering, Claus Steen at tel. +45 2777 0979
 

Qualifications

The ideal candidate holds a M.Sc. or B.Sc. degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.
Furthermore, the following qualifications increases your chances of success in the job:

• Sterilization expertise in EtO sterilization demonstrated by certificate from sterilization training and/or experience from prior work assignments.

• Specialist in Quality Assurance processes in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Cybersecurity, Design Verification and Validation, Design planning.

• QA experience from the medical device or IVD industry or other similar regulated industries.• Knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and IVDR/MDR).

• Process development and lean thinking.

• Structured person with skills for planning and visual management.

• Drives process improvement projects forward to reach pivotal objectives and makes things happen and follows through.

The job requires you to be fluent in English both verbally and in writing. 

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jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

source: DK-STAR