Quality Assurance Supervisor/Specialist
The department for Quality Assurance & Regulatory Affairs is looking for a new colleague to strengthen our team. Quality Assurance works to ensure compliance with regulations and to secure that the products meet all specifications prior to release. The department plays a crucial role in implementing improvements and to serve support to all staff in all quality related issues.
We are searching for you who:
· Like to work systematic and accurate
· Enjoy working interdisciplinary with other departments
· Can extract the essential from complex information
· Enjoy new challenges
· Show initiative
· Are persistent
Work tasks
· Release products for sale
· Approve procedures and work instructions
· Follow up and close non-conformances, complaints, changes and CAPAs
· Approving technical documentation, including protocols and reports
· Train and give advice to staff in other departments on quality related topics
· Perform internal and external audits
Preferred qualifications and experience
· Higher degree in science/technology (minimum M.Sc or equivalent)
· Minimum 3 years relevant experience working with QMS and GMP
· Previous experience from ISO13485 or regulatory affairs is an advantage
· Experience within Electronic Quality Management System is an advantage
· Good communication skills in English (oral and written)
· Good IT skills and use of standard MS Office tools
Personal skills
· Ability to work organized and precisely
· Independent, but with good collaboration skills
· Hard working and flexible
· Organized and patient
· Motivated by working towards a common goal
What we can offer?
For the right candidate we offer an exciting career opportunity in an innovative and fast-growing global company. We offer great potential for personal and professional growth with good conditions and competitive wages.
Om bedriften
Gentian AS is a company in the Gentian Diagnostics Group and is headquartered in Moss (Oslo), Norway, with representation in China, Sweden and USA. Gentian´s employees (around 40 persons of varied age and nationality) develop, manufactures, produce and market highly-sensitive diagnostic reagents and methods for the global clinical laboratory market. Gentian´s products have gained substantial market share due to their high quality from utilizing our proprietary technology for nanoparticle enhanced diagnostic tests. We serve the global market for both human and veterinary medical diagnostic tests.
Gentian AS coordinates several well-funded international R&D projects partnered by leading clinical and commercial organizations using nanoparticle-based technologies invented and owned by Gentian AS. A number of exciting and original diagnostic products are in the pipeline, and new employment opportunities are being created.
The position reports to the Vice President of Quality Assurance & Regulatory Affairs.