Senior QA/RA Engineer

Senior QA/RA Engineer - Medical Devices

Are you experienced in QA/RA Specialist within the medical device industry? Do you thrive in a dynamic environment, working with a variety of innovative products? If so, we are looking for you!

Our client is seeking a Senior QA/RA Engineer to join their team. This is a unique opportunity to take on a lead role within a multidisciplinary organization, working closely with internal teams and external partners. The ideal candidate will bring several years of experience in the development and certification of medical devices and the ability to navigate complex regulatory challenges.

Your Responsibilities

As the Senior QA/RA Lead, you will play a key role in the Life Science and Health Business Unit, overseeing QA/RA activities at both the project and business level. You will ensure that all design and development processes for medical device products comply with industry standards and regulatory requirements.

Key tasks include:

• Leading QA/RA efforts across multidisciplinary project teams, particularly for medical devices and software.
• Defining regulatory strategies in collaboration with clients and advising development teams on certification requirements.
• Ensuring compliance with quality systems, safety protocols, and applicable regulations, including MDR and ISO13485.
• Managing external audits and facilitating internal quality audits.
• Overseeing the preparation of technical documentation for certification.
• Addressing complex regulatory challenges and providing solutions.
• Coordinating CAPAs (Corrective and Preventive Actions) and following up on action plans and KPIs from management reviews.

What You Bring

• A Master’s degree in Biomedical Engineering, Health Sciences, or a related technical field.
• At least 5 years of experience in QA/RA within the medical device industry, with a strong knowledge of MDR and ISO 13485.
• Excellent analytical skills and the ability to communicate effectively with both engineering teams and clients.
• A pragmatic yet thorough approach to balancing regulatory requirements with project objectives.
• Experience in conducting and guiding audits and managing compliance issues.