Quality Assurance (QA) Manager to Inossia AB

QRIOS AB; Stockholms kommun; On-site; SEK 600,000 - 800,000; Full time

Job summary

Inossia AB is seeking a full-time Quality Assurance (QA) Manager based in Stockholm. The role involves managing the Quality Management System (QMS) and ensuring compliance with ISO standards. Responsibilities include overseeing product releases, conducting audits, and supporting supplier quality management.

The ideal candidate has extensive QA experience in the medical device industry, strong knowledge of ISO 13485, and proven audit experience. The company promotes a dynamic workplace that values contributions towards improving fracture treatments for osteoporotic patients.

Qualifications

• Multiple years of QA experience within the medical device industry, preferably in a smaller-sized company.
• Strong hands-on knowledge of ISO 13485 and ISO 14971.
• Proven experience leading and supporting audits and inspections.

Responsibilities

• Lead and improve the Quality Management System in accordance with ISO 13485.
• Ensure compliance throughout the medical device product lifecycle.
• Oversee risk management activities and support audits.

Skills

QA experience in medical device industry

Knowledge of ISO 13485 and ISO 14971

Experience in auditing and inspections

Cross-functional collaboration

Fluency in English

Job description

Inossia is now recruiting a Quality Assurance (QA) Manager. The position is full‑time and based in our headquarters office in Stockholm. It is designed for a new colleague to join Inossia's team.

Inossia aims to improve fracture treatment for osteoporotic patients, providing vertebral augmentation solutions tailored to the mechanical properties of bone. The company is entering a pivotal growth phase with the launch of its first product and the transition from development to commercial operations while maintaining a commitment to ongoing research.

As a QA Manager you will manage our QMS and oversee product releases. You will lead training on new SOPs, collaborate closely with the Production Manager to ensure accurate and compliant documentation, prepare the organization for audits, and conduct supplier audits.

Responsibilities

• Lead, maintain, and continuously improve the Quality Management System in accordance with ISO 13485 and applicable medical device regulations.
• Ensure compliance throughout the medical device product lifecycle, from development and design through manufacturing, release, and post‑market activities.
• Oversee risk management activities, including risk files, benefit‑risk analysis, and lifecycle updates.
• Plan, conduct, and support internal and external audits, including notified body, supplier, and regulatory audits.
• Act as a key point of contact for audit readiness, responses, and corrective actions.
• Manage CAPA, non‑conformances, deviations, and change control processes.
• Collaborate cross‑functionally to ensure quality is embedded across the organization.
• Support supplier quality management, qualification, and ongoing performance monitoring.
• Ensure robust documentation control, version management, and data integrity.
• Contribute to key strategic developments within the QA department.

Your Profile

• Multiple years of QA experience within the medical device industry, preferably in a smaller‑sized company.
• Strong hands‑on knowledge of ISO 13485 and ISO 14971.
• Proven experience leading and supporting audits and inspections.
• Solid understanding of medical device quality systems, risk management, and product development processes.
• Experience working in cross‑functional, international environments.
• Fluency in English, both in speaking and in writing.

We are looking for someone with a can‑do attitude, strong organizational skills, and a quality‑driven mindset. You enjoy taking ownership, managing priorities, and working independently or as part of a team. You are analytical, detail‑oriented, and can effectively combine flexibility with strong decision‑making ability. You also thrive in a dynamic workplace where people matter and your contributions create a positive impact.

About Inossia AB

Inossia aims to improve fracture treatment for osteoporotic patients so that they can live an active life. We are launching our first product and transitioning to commercial operations, while continuing research to advance spine‑care solutions. We completed a clinical study of 196 patients in 4 countries and 9 clinics, and received Breakthrough Device Designation for Inossia Cement Softener in June 2025.

Contact

For more information about the position, please contact:

Krishan Johansson Haque, PhD
Sr Recruitment Consultant, QRIOS Life Science & Engineering
T: [phone]
E: [e-mail]