Quality Assurance (QA) Manager to Inossia AB

QRIOS; Stockholms kommun; Hybrid; SEK 900,000 - 1,150,000; Full time

Job summary

Inossia AB is seeking a QA Manager to lead our Quality Management System and ensure compliant product releases from our Stockholm office. You will drive training, audit readiness, and cross-functional collaboration to embed quality across the organisation.

You will report to the QA/RA Director and work with Production to secure documentation integrity, CAPA handling, and lifecycle risk management in a growing medical device company.

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.
• 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.

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 organisation.
• 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.

Skills

QA experience

ISO 13485

ISO 14971

Audit leadership

Risk management

Product development

Cross-functional

English fluency

Job description

Inossia is now recruiting a Quality Assurance (QA) Manager to the company. The position is full-time and based in our headquartered office in Stockholm and we are looking for a new colleague to join the team at Inossia.

Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia® provides vertebral augmentation solutions that have been adapted to the mechanical properties of bone that will give Better fracture treatment for Osteporotic Bone. The company is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care

As a QA Manager, you will be responsible for managing our QMS and overseeing product releases. You will lead training on new SOPs and collaborate closely with our Production Manager to ensure accurate and compliant documentation. Additionally, your responsibilities will include preparing the organization for audits and conducting supplier audits.

At Inossia, you will get the unique opportunity to build, shape and optimize our processes from the inside out, make a positive impact and apply your experience and expertise within QA to ensure the highest quality standards. If this sounds interesting to you - Come join us and be part of our mission of improving fracture treatment for osteoporotic patients so that they can live an active life.

Responsibilities

The QA Manager will have a central role in oversight and management of manufacturing and analytical activities from a quality perspective. You will report directly to the Director of QA/RA at Inossia.

Your main responsibilities will include:

• 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 organisation

• 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

Key Qualifications for the position include:

• 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 and accountability to drive continuous improvement of the quality system and work well both independently and in team settings. You can handle multiple tasks and manage priorities in a timely manner and have excellent collaboration and communication skills. You are analytical, detail- and result-oriented and can effectively combine flexibility with a strong decision-making ability. Importantly, you enjoy a dynamic place of work where people matter, and your contributions will make a positive impact.

About Inossia AB

Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life.

Inossia is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care

• Inossia has completed a clinical study of 196 patients in 4 countries and 9 clinics

• Inossia received the Breakthrough Device Designation for Inossia Cement Softener in June 2025

To learn more, please visit www.Inossia.com

For more information about the position, please contact:

Krishan Johansson Haque, PhD

Sr Recruitment Consultant, QRIOS Life Science & Engineering

T: [phone]

E: [e-mail]