Job Description

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.

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.