QA Manager, Medical Devices — ISO 13485 Expert

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 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.