Quality Assurance Specialist | Thor Companies
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ABOUT THE ROLE

Thor Companies is looking for a Quality Assurance Specialist on behalf of the client.

 

Location: Stockholm – hybrid work setup

 

Position Overview:

As a Quality Assurance Specialist, you will handle a broad range of manufacturing-related QA tasks, including batch record review and release, deviation and CAPA management, and collaboration with contract manufacturers (CMOs) to ensure proper implementation of procedures and corrective actions. You will work closely with and support the client’s QA Manager and production teams. This role is ideal for someone who thrives in a dynamic environment and enjoys enhancing processes, facilitating batch releases, and ensuring compliance and continuous improvement within the QA field.

 

Key Responsibilities:

 

Review batch records and release batches.

Collaborate with Supply Chain, Sales, and CMOs to investigate and resolve deviations from established processes and implement corrective actions.

Lead CAPA investigations and manage the implementation of corrective and preventive actions in collaboration with CMOs and internal stakeholders.

Conduct root cause analyses for manufacturing issues and contribute to effective CAPA planning.

Support the QA Manager in developing the Quality Management System (QMS) and related processes.

Investigate and manage external product-related complaints.

 

Qualifications:

 

Bachelor’s degree in a relevant field (e.g., Engineering, Quality Assurance).

Approximately three years of quality assurance experience 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 regulatory and medical device standards, including MDR and ISO 13485; FDA regulations are a plus.

Proficiency in English; Swedish is desirable but not essential.

 

Personality Traits:

 

Detail-oriented and highly organized with a structured approach.

Resilient and adaptable with a can-do attitude.

Strong interpersonal and communication skills for effective collaboration with internal teams and external stakeholders.

 

About the Client:

The client is a Swedish biotech company at the forefront of biomaterial science, producing innovative medical products that address structural imbalances associated with aging. After achieving CE certification for their first product in 2021, they are pursuing an ambitious growth strategy in the aesthetic dermatology market and expanding into multiple therapeutic areas.

 

The role is based in central Stockholm with a hybrid work setup and requires regular travel to CMOs in Uppsala and Malmö.

Sounds interesting?

Apply Now

SIMILAR ROLES

+44 203 475 84 31
68-70 S Lambeth Rd, Vauxhall London SW8 1RL