Interested in joining Qity?

Role Description

We are seeking a dedicated and detail-oriented Junior Quality Assurance and Regulatory Affairs Analyst to join our team. In this role, your primary focus will be on delivering high-quality QA and RA services to our clients, helping them navigate through complex regulatory requirements and achieve their quality objectives. You may also occasionally support the development and deployment of our proprietary iQMS solution. As a junior role, Qity is committed to supporting your professional development, and this position will offer a unique opportunity to develop valuable skills in Medical Device Development, Regulatory Environments, Test Management, Validation, Verification, and many other areas.

Responsibilities

• Deliver high-quality QA and RA services to our clients, ensuring their compliance with ISO 13485, ISO 80002-2, ISO 14971, IEC 60601, IEC 61010, and IEC 62304.
• Assist clients with gap analyses and assessments of their current Quality Management Systems, particularly with view of improvements and, potentially, deploying Qity’s iQMS.
• Aid in the development and implementation of Quality Management Systems for our clients, in compliance with ISO 13485.
• Conduct internal and supplier audits for clients to ensure the effective and efficient operation of their Quality Management Systems.
• Assist in developing regulatory strategies that align with our clients' business objectives and goals.
• Perform risk management activities, including hazard analysis, FMEA, and risk analysis, in compliance with ISO 14971 and applicable product standards.
• Occasionally support the ongoing development and refinement of Qity's proprietary iQMS solution.

Qualifications

• Bachelor’s degree in Engineering, Quality Assurance, or related field.
• Prior experience in a quality assurance or regulatory affairs role is a plus, but not required.
• Familiarity with ISO 13485, ISO 80002-2, ISO 14971, IEC 60601, IEC 61010, and IEC 62304 standards.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to work independently and as part of a team.
• Ability to manage multiple projects and meet deadlines.

At Qity, we are committed to the professional development of our team. The successful candidate will receive comprehensive training and support, gaining valuable skills and experience in various areas of medical device development and regulatory compliance.

If you have a passion for developing medical devices, an eagerness to learn, and a desire to work in a fast growing MedTech start-up, we encourage you to apply for this opportunity.