VP , QA & Regulatory Affairs
DDD- Diagnostic a/s www.ddd-diagnostic.dk is well known within the nuclear medicine industry as world leading manufacturer of accurate and innovative gamma camera systems. Focusing on Danish Design and Danish Quality, DDD has become market leader within nuclear cardiology as an OEM manufacturer working with the major international corporations, supplying diagnostic imaging equipment worldwide. Now, DDD is also marketing a range of gamma camera systems under the DDD brand. DDD-Diagnostic currently accounts approx. 35 employees in Denmark and a wide range of distributors world wide.
Reporting to the CEO, you will ensure all quality assurance activities at the production site in Hørsholm regarding maintenance and improvement of the quality system.
You will assure that all processes meet the internal and external requirements including SOP reviews, and ensure validation and qualification of the Medical Equipment produced in Hørsholm and at Suppliers.
In addition, you will take an active role in managing Regulatory Affairs, including leading and implementing approval activities in local markets, and document approval in connection with qualification.
You will work with development of the quality system and the procedures for equipment and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation in a LEAN-oriented environment. Whereas the position requires leadership skills, implementation itself will also be a significant part of the daily tasks. Furthermore, you will identify and contribute to meet the company’s international customers’ demands for equipment quality.
You will work with development of the quality system and the procedures for equipment and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation in a LEAN-oriented environment.
You hold a relevant academic degree e.g. MSc. Engineering, MSc. Pharm, Cand Scient. with at least 5 years’ of QA experience within medical equipment. DDD-Dianogstic operates both in a national and international environment and therefore you must – in addition to Danish – speak and write English fluently.
You are business oriented and determined on creating world-class results and ensure quality of the highest order. Moreover, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills into play and you like to work with many stakeholders. You are able to adapt but also challenge the way of working so that DDD-Diagnostic constantly improve their methods and processes.
This recruitment process is carried out in cooperation with ADVANZ. For further information, please contact Partner Rikke Pihl on +45 70 20 33 02. Please apply through this website and attach your application and CV in English. All applications will be handled in the strictest confidence. Please be aware that we return a confirmation to the e-mail address that you type in the form.
It is easy to apply for a position at ADVANZ. You just fill out our online application form and then we have the information we need in the first place. We guarantee you obviously full confidentiality throughout the application process. Confidentiality is fully appplied whether you are employed by one of our clients or not.
|Job location||Denmark, Hørsholm|
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