Quality Assurance Compliance Specialist

About Scopio Labs

Scopio Labs is a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global – and every individual at Scopio Labs is part of a life-saving mission.

About the job

We are looking for a Quality Assurance Compliance Specialist to join our compliance and RA team, which plays a central role in both pre-market and post-market activities. The team is responsible for Scopio’s regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.

The Quality Assurance Compliance Specialist will play an important role in the company’s regulatory, quality and compliance activities, such as ensuring compliance with relevant quality standards (including ISO 13485:2016, 21 CFR 820, MDSAP and IVDR); supporting internal audits, corrective efforts and different quality projects; and defining quality procedures, protocols and tools.

As an analyst, you will:

• Provide ongoing support for the company’s quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
• Maintain the company’s quality management system (QMS)
• Evaluate and address quality assessment related to customer complaints
• Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
• Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
• Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
• Analyze post-market surveillance data to support company initiatives
• Prepare teams for internal and external audits

The ideal candidate will have::

• Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
• At least three years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
• Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
• Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
• Ability to collaborate effectively with cross-functional teams to achieve quality objectives
• A motivated, collaborative, and proactive approach to work
• Team orientation
• Excellent communication skills (both written and verbal)
• Strong attention to detail
• Ability to lead and implement processes
• English proficiency