RSP Systems A/S was founded in 2006 as a spin-out from the Biophotonics Group at the University of Southern Denmark (SDU). RSP Systems A/S develops a non-invasive glucose measuring device based on Raman Spectroscopy. Following the successful development and clinical investigation, the company prepares for market approval and launch of its first commercial product. Developing the organisation to cope with this task, RSP Systems is looking for a Quality Assurance Director to establish and maintain a quality management system.
Main Roles & Responsibilities
The main task is to manage all quality aspects effectively conforming to FDA quality system regulation 21CFR820.
The QA Director will act as a management representative and will be managing a team of QA engineers. Further, it is of major importance to support the specific R&D activities related to complex technologies such as artificial intelligence, machine learning, optoelectronics involving lasers and mechanics, help the organization evolve, grow, and transform, and prepare for the launch of its first medical device at the relevant and necessary quality requirement.
Experience/Knowledge – Qualifications
The candidate must have a background in engineering or similar and several years of experience with quality management systems relating to the medical device industry. The ideal candidate must meet several of the following criteria:
- Experience with international QA systems
- Professional experience with FDA market authorization procedures and audits
- Understanding of and experience with QA aspects of medical device development processes, including Medical Device Regulation, CE marking and ISO 13485
- Excellent written and oral communication and presentation skills
- People management experience
- Ability to prioritize tasks and resources, meet deadlines and be flexible to changing priorities
The ability to delivering results is the most important personal competence for being successful in this position:
- Strong interpersonal and communication skills
- Result-driven and a doer
- Team player
- Leadership capabilities and abilities to create results in a cross-functional role
- Highly organized and detailed-oriented
- Flexible and the ability to meet deadlines
- Ability to prioritise tasks
- Taking initiative and exhibiting hands-on mentality
For more information about RSP Systems, please see www.rspsystems.com
Copenhagen area or Odense.
Interviews will be conducted on an ongoing basis, so please do not hesitate to send your application, and always feel welcome to contact SAM International A/S for further details - Senior Consultant Peter Samuelsen - firstname.lastname@example.org, +45 40580568.
Please note that due to GDPR rules, we do not accept applications/CV via e-mail.