Malsen Medical is a consultant company within the medical and scientific fields of Medical Devices, IVD and Pharma. The company is growing, and we aim to strengthen our team in Norway with a Quality Assurance Manager to help our international team with introducing new and innovative products, to a global market through an ever-growing European network of clients.
Our new Quality Assurance Manager is accurate and detail oriented. You will be responsible for projects within medical devices, IVD and Pharmaceuticals. Our new colleague will be a key figure for Malsen, and you will be working on projects that have a big tangible impact.
Key responsibilities:
- Monitor all quality related activity in the project
- Attend client quality management meetings
- Control the distribution on all of the company’s quality documentation
Qualifications:
- Minimum BSc degree and preferably a MSc degree in relevant scientific fields (engineering, pharmaceutical, elsys)
- Experience as a Quality Manager/Quality Control in medical devices, Vitro Diagnostics or Pharmaceutical industries (pharmacy or distribution)
- Knowledge of quality management systems such as ISO 9001, ISO 13485, FDA CFR820, ICH Q10 or similar
- Highly proficient in spoken and written English and in spoken Norwegian
- Professionally written and spoken English level and Norwegian spoken level (German will be an advantage, but not a necessity)
Preferable experience from:
- Leading external and internal audits
- Change control and CAPA processes
- Development, production and distribution of medical products
- Electronic quality management and ERP systems
The ideal candidate is motivated and has a high work capacity. An excellent Quality Assurance Manager is able to handle several projects simultaneously, which means that you are structured and focused. It is important that you have a strong attention to details in challenging situations and are able to stay calm during stressful event.
What you will receive from us:
- Becoming a part of a team with extensive knowledge in several scientific fields
- A challenging and exciting workday, where each day differ
- Project based time abroad (preferably Paris/Nice) if desired
- Flexible office location – Offices in Oslo, with the opportunity to work from home
If interested - please contact Partner Steinar Nilsen (991 00 436 / sn@capus.no) or Researcher Kristian Carlstedt (452 94 338 / kc@capus.no).