Production /QA Manager to Nordberg Medical AB

Nordberg Medical AB is a Swedish MedTech company based in the Karolinska Science Park, Stockholm. The company is committed to the development, manufacturing, marketing, and sale of high-end medical devices that focus on cutting-edge biomaterials. Nordberg Medical AB is the daughter company of a global leader in the development and production of medical grade polylactic acid, that has among its shareholders leading PE and VC investors. With strong R&D resources, Nordberg Medical is poised to expand into multiple lines of medical device products covering fields such as aesthetics, orthopaedics, trauma surgery, sports medicine, neurosurgery, and plastic surgery.

Nordberg Medical AB passed a significant milestone in 2021 by receiving CE certification for its PLLA (Poly-L-Lactic Acid) based collagen stimulant, JULÄINE™, positioning the company well to pursue an aggressive growth strategy for the aesthetic dermatology market. JULÄINE is manufactured by a CMO in Sweden.

Nordberg Medical AB has also initiated an FDA application that will support entry into the US and additional key markets.


About the position
The Production/QA Manager ensures that the manufacturing and distribution of Nordberg products are performed in compliance with according to European Medical Device regulations. The Production/QA functions will take a wide range of responsibilities including but not limited to: production (eg. CMO) establishment and development, validations, batch management, maintenance of quality agreements, review of analytical reports and product release for sale, product inspection (audits) and preparation and development of Standard Operating Procedures.

Key Responsibilities

1. Manage the development and establishment of the production
2. Manage the CMO in terms of CMO alternative selection, quality agreement establishment, project plan implementation, validations, review and approval of production and QC documents, SOPs and reports, product release etc.
3. Open to learn and gradually take QA responsibility with the help of consultants
4. Support and coordinate the production audits from the authorities and customers
5. Audit the production sites on the regular basis to ensure the compliance with ISO13485 requirements
6. Manage and evaluate product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs)
7. Manage the production to satisfy the US FDA and EU MDR requirements


Your profile
Professional Experience/Qualifications

• B.Sc. in Science
• Solid background in manufacturing pharmaceutical or medical device products
• Experience in development, establishment, and managing production through CMOs
• Knowledge and experience with GMP/European ISO 13485 quality systems
• Detail oriented and solid decision making skills
• Excellent communication skills

Working and employment conditions:

With our priority on productivity and communication, we take a flexible approach to working location. In consultation with senior management, the successful candidate will be able to combine working remotely and from the company’s headquarters in central Stockholm. Regular attendance for group meetings is required.

The position will be full-time employment, with terms and conditions fully respecting all Swedish laws and regulations. Core to Nordberg’s mission is to be a stand-out employer.