As Quality Assurance Specialist, you will work with the full scope of manufacturing related QA task, running from batch recorded review and release, deviation and CAPA management and collaborating with our contact manufacturers (CMO´s) to ensure proper implementation of our procedures and corrective actions. You will work closely with and support the CMO production. This position is designed for an individual who thrives in a dynamic environment and is passionate about working closely with production teams to enhance processes, facilitate batch releases, and manage deviations and CAPA to ensure compliance and continuous improvement within the QA field.
Key Responsibilites
Your responsibilities will include, but not be limited to:
- Review batch records and release batches.
- Lead and collaborate with Supply Chain, Sales and CMO´s to investigate deviations to ensure resolution of deviations from established processes, collaborating with production to implement corrective actions promptly.
- Lead CAPA and complaints investigation and manage and facilitate the implementation of Corrective and Preventive Actions (CAPA) in collaboration with the CMO and internal stakeholders.
- Conduct root cause analyses for issues identified during manufacturing and contribute to the development of effective CAPA plans.
- Support the QA manager in development of the QMS and QA related processes.
- Manage and investigate external product related complaints.
Qualifications
- Bachelor's degree in a relevant field (e.g., Engineering, Quality Assurance).
- Around 3 years of experience in quality assurance within production in the medical device (class III or IIb) or pharmaceutical industry.
- Strong understanding of batch release processes, deviation management, and CAPA implementation.
- In-depth knowledge of relevant regulatory and medical devices standards.
- Knowledge and experience in MDR and ISO 13485. Knowledge on FDA regulations is preferred.
- In-depth knowledge of relevant regulatory standards, including ISO 13485 and FDA regulations is preferred.
- Excellent written and oral communication skills in English. Proficiency in Swedish is desirable, but not essential.
Personality
- Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.
- Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
- Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders.
Other information
This role is based at our CMO site in Malmö. Regular travel to our HQ in Stockholm and CMO in Uppsala will be needed.
