QA Manager, Medical Devices - ISO 13485 & Audits

QRIOS AB; Stockholms kommun; Vor Ort; SEK 600.000 - 800.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QA experience in medical device industry

Knowledge of ISO 13485 and ISO 14971

Experience in auditing and inspections

Cross-functional collaboration

Fluency in English

Jobbeschreibung

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.