Quality Assurance Consultant (Medtech)

TL;DR

Quality Assurance Consultant (Medtech): Managing compliance and quality assurance projects for biotech, med device, and pharmaceutical clients with an accent on GxP, GMP, and GDP compliance. Focus on handling product quality complaints, implementing CAPA to resolve deviations, and developing quality systems through SOP writing.

Location: Must be based in Sweden. Hybrid and remote work options are available.

Company

A consulting firm providing end-to-end regulatory sciences, clinical research, and quality compliance expertise to biotech, med device, and pharmaceutical organizations.

What you will do

• Manage product quality complaints and handle various GxP requests for clients.
• Represent the company in assigned quality assurance areas and execute risk-based GxP projects.
• Provide consultation for the implementation of CAPA to resolve deviations and non-conformances.
• Ensure compliance of operations with quality principles and develop quality systems through SOP writing and training.
• Directly engage and educate employees at all levels on compliance and quality assurance to drive improvement.
• Promote continual improvement regarding customer satisfaction for CQA consulting services.

Requirements

• Bachelor’s degree or similar college degree in a scientific discipline.
• Minimum 2 years of relevant experience in quality assurance and regulatory / GxP compliance.
• Fluency in English is a must.
• Strong analytical skills, quality orientation, and high attention to detail.
• Ability to manage and execute multiple tasks within compliance and quality assurance.

Nice to have

• Fluency in Finnish or Swedish.
• Knowledge of applicable EMA and MHRA regulations and guidance documents.

Culture & Benefits

• Commitment to diversity, equity, and inclusion, creating a workplace for authentic self-expression.
• Culture that encourages innovative, collaborative, and entrepreneurial spirits.
• Flexible work arrangement supporting remote work with encouraged hybrid collaboration near office locations.
• A safe and empowering environment designed for employee success.
• Transparent hiring process with a guaranteed outcome for every applicant.