SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.

To our Targeted Deliveries segment, the business unit SmartWise Sweden AB, are we now seeking a QA Manager, Production to join our growing Quality & Regulatory Affairs (QARA) team.

About the position

We are on an exciting path of growth and innovation and are now looking for a detail-oriented and organized professional with knowhow and experience in medical device development and production.

In this role, your main responsibility is to ensure quality assurance and regulatory compliance within our planned production facility and cleanroom. You will play a key part in establishing and maintaining standards and work instructions for compliant and efficient production processes that meet medical device standards and regulatory requirements.

Your scope will cover the full range of in-house manufacturing QA activities — from batch record release, deviation and CAPA management, and validation oversight, to providing strategic quality input on equipment, systems, and post-launch changes. You will also collaborate closely with suppliers and contract manufacturers to ensure consistent quality performance throughout the supply chain.

In addition to your primary responsibilities, you will assist the QARA team in activities related to the development and maintenance of the quality management system, provide QA/RA support for development projects, and contribute to regulatory activities, including authority reporting and submissions.

Your responsibilities will Include, but not be limited to

- Work with Production to enhance understanding and application of quality standards and promote proactive quality practices.

- Support Production to establish standards and work instructions for compliant and efficient production processes.

- Integrate risk management into Production by conducting risk assessments and utilizing pFMEA outputs to guide the quality strategy.

- Lead validation activities for manufacturing processes, equipment, system, and product changes to ensure compliance with quality and regulatory standards.

- Review and release production batch records.

- Coordinate with Production to manage supplier quality performance and incoming inspection effectiveness.

- Lead and collaborate with Production, Supply Chain, Sales and CMO´s to investigate deviations and CAPAs.

- Analyse trends within Production to drive continuous improvement.

- Act as Quality Regulatory representative in product development projects, including risk management activities.

- Coordinate continuous transitions from Development to Production, providing feedback and implementation assistance.

- Assist Clinical Affairs in work related to clinical trials.

- Assist the QA manager in development of the QMS and QA related processes and activities; compliant handling, audit, change control, management review, training etc.

- Assist Regulatory Affairs to develop and manage regulatory strategy for Targeted Delivery’s portfolio of Class IIb and Class III products.

- Assist Regulatory Affairs for putting together technical files and submission dossier.

Who we are looking for

We are seeking an experienced and hands-on Quality professional with a strong background in medical device development and manufacturing. You thrive in a dynamic environment where structure and innovation must coexist, and you have a pragmatic, solution-oriented approach to quality management.

You combine a solid understanding of ISO 13485 and relevant regulatory frameworks (such as MDR and FDA 21 CFR 820) with practical experience implementing and maintaining compliant production processes. You are comfortable working across fields, from R&D and Development to Production and Supply Chain, from quality assurance to regulatory affairs, and you know how to translate quality requirements into efficient operational practices.

To succeed in this role, you should have:

• University degree in engineering, life sciences, or a related technical field.

• Strong knowledge of medical device QMS principles, originating from ISO13485, 21 CFR Part 820 and MDR. Previous experience from class III devices is an advantage.

• >3 years of experience in quality assurance in the medical device industry, with documented experience from manufacturing. Cleanroom experience is an advantage.

• Proven ability to interpret and apply regulatory requirements to practical Production challenges.

• Excellent communication skills and the confidence to influence and support cross-functional teams.

• A proactive mindset, attention to detail, and the ability to balance compliance with operational efficiency.

If you’re motivated by building quality into every step of production and want to contribute to bringing innovative medical technologies to market, SmartWise offers a role with real impact and growth potential. Fluency in English is mandatory, Swedish highly preferred.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities.