Senior QA Manufacturing Specialist
- Application Deadline: June 30, 2026
- Stockholm
- Hybrid
We are looking for a Senior QA Manufacturing Specialist at Nordberg Medical, you will support Nordberg Medical's global expansion by ensuring the ramp up of the production of current and future products. This could be a great opportunity for you if you are motivated by working with innovative medical products and project management in a scale up environment.
You will be joining our multicultural Quality Assurance team, which includes highly competent colleagues in multiple countries. This position will play a key role in various projects with the aim to scale up and improve the manufacturing process.
Key Responsibilities
Your responsibilities will include, but not be limited to:
- Provide technical input in a broad range of areas related to design, production, cleaning, packaging, and sterilization by ionising irradiation (e.g. gamma, e-beam).
- Work with QA/RA department developing of relevant documentation(e.g. SOPs, Work instructions, batch records, etc).
- Manage and maintain effective communication with CDMOs, as batch release activities rely on external manufacturing partners.
- Support production audits from the authorities.
- Maintain a flexible approach to collaborating on projects across all departments of the company and with consultants engaged by the company.
Skills & Requirements
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.
- For this position, it is very relevant experience in remote manufacturing setups.
- 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.
Beneficial Qualifications
- Experience in remote manufacturing setups.
- Technical knowledge related to design, production, cleaning, packaging, and sterilization by ionising irradiation (e.g. gamma, e-beam).
Personality
- You approach responsibilities with enthusiasm, and you consistently take the initiative to excel in your work.
- You have an adaptive, can-do attitude, demonstrating both persistence and flexibility when facing challenges.
- You thrive in collaborative settings, working seamlessly within cross-functional teams to drive successful outcomes.
Other information
This position is based at our central HQ in Stockholm, at Klarabergsviadukten 63. We have a hybrid work model, working primarily from the office with occasional flexibility to work from home.
This role requires travelling for meetings in and outside Sweden.
Why should you join our team?
- We are a global, inclusive team where innovation and creativity are actively encouraged, empowering you to make a meaningful impact.
- An opportunity to develop your career in a dynamic and collaborative environment.
- Join us to embark on a journey committed to delivering innovation and improving lives.
Work with great people
About the company
Nordberg Medical is a Swedish biotech company working at the forefront of biomaterial science to reverse functionality loss. With state-of-the-art biomaterials, we produce and market innovative medical products that target structural imbalances associated with aging.
In 2021, we passed a critical milestone by receiving CE certification for our first product. JULÄINE™ of Sweden is a biostimulator that activates natural collagen production in the skin. This positions the company well to pursue an ambitious growth strategy in the aesthetic dermatology market.
Backed by leading investors and extensive R&D, we are expanding across multiple therapeutic areas and geographies.
Join an international team of highly talented individuals where your contribution counts. We promote a culture of entrepreneurship, multiculturalism, and flexibility in more than ten countries. At Nordberg Medical, you will have the opportunity to grow and learn, to be creative, and to contribute to both our product and company success.
Add the title below:Our values
Ambitious- Self-drive supports the collective ambition of the company. - We are the front runners in next generation biomaterials. - We develop the business through continuously learning from our experiences. - We reward achievements and celebrate progress along the way. - We focus on the solution when faced with setbacks.
Unique- We transform the market with breakthrough innovation. - We prove uniqueness through science and outstanding partnerships. - We embrace differences as strengths by including different viewpoints in our business. - We encourage our teams to develop current business practices with innovative ideas.
Accountable- We put the customers at the core of everything we do. - We deliver on promise and communicate with honesty. - We take responsibility for all our actions and the resultant outcomes. - We recognise and embrace our responsibility for a positive impact on stakeholders and communities.
United- We achieve success through joint efforts and teamwork. - We develop partnerships through a strong belief in the product and mission. - We bridge differences by assuming good intent and acting in the best interests of each other.
Emelie Wedin | Contact Person
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