Quality Assurance Officer (Medical Devices)

Location: Fully remote across Europe; candidates must hold a valid work permit in their country of residence.

Company

hirify.global is a global testing, inspection, and certification company operating offices and laboratories worldwide.

What you will do

• Maintain the NB 1639 medical device internal quality management system.
• Update and maintain documents under the MDD, MDR, and IVDR schemes.
• Manage complaints, compliance queries, appeals, continual improvement, document control, and records.
• Perform quality assurance checks and release updated quality management documents in Bizzmine.
• Manage the IF database, publish documents on the hirify.global website, and support combined scheme documentation.
• Provide technical support and collaborate with global medical device certification, competency, technical, and clinical teams.

Requirements

• Significant experience in a position with quality assurance responsibility.
• Strong working knowledge of quality management systems, including CAPA management, document control, and good documentation practices.
• Bachelor’s degree or higher in Biomedical Sciences or a related field such as pharmacy, bioengineering, or nursing.
• Strong organisational skills, attention to detail, flexibility, and the ability to manage priorities independently and work effectively in a team.
• Good working knowledge of Microsoft Word, Excel, and Outlook.
• Fluent written and spoken English; a valid work permit in the country of residence is required.

Nice to have

• Detailed knowledge of MDD, MDR, IVDR, ISO 17021-1:2015, ISO 13485, and ISO 9001.
• Medical device experience or auditing experience against recognised standards.
• Training in MDD, MDR, IVDR, or ISO 13485, or medical device auditor qualifications.

Culture & Benefits

• Flexible schedule and fully remote work model across Europe.
• International environment with collaboration across multiple continents.
• Access to hirify.global University and Campus for continuous learning.
• Comprehensive benefits platform and opportunities for professional development.
• Open, supportive culture focused on teamwork, diversity, quality, and sustainability.