Senior QA Manufacturing Specialist
HybridStockholm, Stockholm, Sweden or Uppsala, Uppsala, Sweden
EXPIREDStockholm, Stockholm, Sweden or Uppsala, Uppsala, SwedenHybridFull TimeSenior LevelBachelors DegreeSmall
Full TimeSenior LevelBachelors DegreeSmall
Job Summary
Provide technical input on design, production, cleaning, packaging, and sterilization via ionising irradiation while developing documentation such as SOPs and batch records. Manage communication with CDMOs for batch release activities and support production audits from authorities. Collaborate across departments and with consultants to scale and improve manufacturing processes in a multicultural Quality Assurance team. This role requires travelling for meetings in and outside Sweden. Based at Nordberg Medical's Stockholm HQ with a hybrid work model.
Required Qualifications
- Bachelor's degree in a relevant field (e.g., Engineering, Quality Assurance)
- At least 5 years' experience in batch release and manufacturing in the medical device (class III or IIb) or pharmaceutical industry
- A thorough understanding of the manufacturing process of medical devices and/or pharmaceuticals
- Strong understanding of batch release processes, deviation management, and CAPA implementation
- Knowledge and understanding of the requirements of EU MDR and US FDA submissions, as well as other relevant regulatory standards, including ISO 13485
- Understanding of technical knowledge related to design, production, cleaning, packaging, and sterilization by ionising irradiation (e.g. gamma, e-beam)
- Excellent written and oral communication skills in English and Swedish
- This role requires travelling for meetings in and outside Sweden
Desired Qualifications
- For this position, it is very relevant experience in remote manufacturing setups
- Experience in remote manufacturing setups
- Technical knowledge related to design, production, cleaning, packaging, and sterilization by ionising irradiation (e.g. gamma, e-beam)
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