id: NDg2NDc0NyA3

reference: 4864747

documentId: 4864747

connectionPointId: 7

lastModificationDate: 1534330686960

stillingsbetegnelse:
QA Specialist and Sparring Partner for Validation of Production Equipment and Software

jobbeskrivelse:

Are you a technically curious engineer, who enjoy being a sparring partner for production improvements related to Medical Devices? Would you like to work with assessing and collaborating with suppliers? Then this job could be your next step in a career journey to learn broadly about Radiometer’s production, suppliers and QA organization. 

Meet your new team

With reference to QA Manager, Albert Bronstein, you join a team of highly skilled and enthusiastic colleagues in an ambitious company. The department is QA responsible for Process Validation, Software validations, Test method validations, Engineering Change Order (ECO) systems and all kind of support to production in relation to Validation. You can look forward to closely collaborat-ing with colleagues from the production and the Procurement/Supply Chain team when you help with supplier collaboration.

Enjoy problem-solving challenges on a daily basis 

One day you might be participating in meetings to ensure validation of big production improve-ment investments. You get to be a trusted advisor when you share your knowledge about how to best validate equipment according to ISO 13485 and QSR during these projects. 

The next day you might be discussing how to best validate the production process of a plastic component or new automation processes with your colleagues from production. 
Finally you might be travelling to visit some suppliers and advise them on how be compliant with our demands and expectations to quality.  

The job

To become successful, you must have experience with QA systems, Validation, ECO and produc-tion support. Your responsibilities and tasks will include:

• QA support to Production in relation to Process validations and Software validations

• Participating in daily support to validation projects

• Participating in activities related to production changes and revalidations 

• QA support to validations and revalidations at Radiometer suppliers

• Daily ECO handling and investigation of production changes

• Participating in other internal projects in QA function, NCR handling, SOP and templates updates

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 Manager in QA, Albert Bronstein at tel. 29131584.

Application deadline is September 9...

But please do not hesitate to apply. Start the application process by pressing "Apply" and follow the guidelines on our corporate career site. We are looking forward to receiving your application.
 

Qualifications

We believe that the following formal qualifications will improve your chances of success:

• Engineering background

• Experience with production and production equipment

• Knowledge of the ISO 13485 and  FDA legislation 

• Knowledge of process validation and revalidation 

• Knowledge with validation of software 

• Knowledge of ECO processes 

• Good English skills, as most documentation is in English. 

• Experienced MS Office user.

You must be passionate and committed about what you do and you benefit from being:

• Positive, open-minded and proactive, adding energy to the team by taking responsibility 

• An excellent communicator, who is used to working with different cultures

• Used to working in team projects, having cross-functional interaction

• Focused on targets and results. Ability to handle and prioritize many projects at the same time and keeping deadlines is necessary

• An analytical and critical thinker

numberOfPosts: 1

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

abstractJV_contact_0:
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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

source: DK-STAR