QA Specialist (2-Year Fixed-Term Contract)

About the role

Join Stryker's Quality Assurance team in Bucharest on a two‑year fixed‑term contract. You will support the local Quality Management System, ensuring compliance with ISO 13485 and medical device regulations while driving continuous improvement.

Key responsibilities

• Maintain and improve the local QMS in line with ISO 13485:2016 and regulatory requirements.
• Develop, revise, and manage QMS procedures, work instructions, and related documentation.
• Execute quality assurance activities and manage nonconformities and CAPAs.
• Support supplier qualification, evaluation, and re‑evaluation, maintaining appropriate records.
• Analyze quality data and trends, informing management of potential QMS impacts.
• Promote a culture of quality, compliance, and continuous improvement across the organization.

Required profile

• Bachelor's degree in a relevant field.
• Experience in the medical device industry preferred.
• Fluent English and strong attention to detail.
• Ability to work in a fast‑paced environment and manage multiple tasks.

Required skills

• Proficiency in Microsoft Office applications.
• Understanding of ISO 13485 standards.
• Familiarity with EU Medical Device Regulation (MDR) preferred.