Location: Cambridge, UK (on-site)

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Opto Bio is a fast-growing, venture-backed company pioneering implantable technologies that interface with the human body to address critical unmet medical needs. We're looking for driven individuals who are passionate about pushing the boundaries of engineering and science to solve some of the most complex biological challenges. In this early-stage environment, we seek versatile team members with a hands-on approach and a willingness to learn quickly and adapt. We value diversity and encourage applicants from all backgrounds to join us in our mission. Learn about our team here!

We are seeking a Sr. Quality Engineer to ensure compliance with all relevant quality standards in the manufacturing of Opto's novel medical devices. This role is critical in establishing, maintaining and enhancing our quality management systems, ensuring adherence to applicable regulations and internal standards. The Sr. Quality Engineer will be responsible for developing and implementing quality standards, inspecting materials, equipment, and processes, training team members to adhere to set standards, and driving continuous improvement initiatives. Key responsibilities include establishing robust quality control systems, identifying and addressing non-conformances, and collaborating cross-functionally to uphold product excellence and patient safety. This role demands deep expertise in the medical device industry, strong leadership skills, and a steadfast commitment to delivering the highest quality products.

Reporting Structure:

This role is an integral part of the quality engineering team and reports to the VP of Engineering.

Key Responsibilities:

• Lead risk management activities, including development and maintenance of risk management files (e.g., FMEAs) in compliance with ISO 14971
• Develop and implement a comprehensive quality strategy aligned with regulatory standards and business objectives
• Prepare and support documentation for regulatory submissions, global registrations, and product changes
• Oversee implementation and updates of SOPs, work instructions, test methods, processes, and labelling to ensure regulatory compliance
• Establish and manage reliability targets, testing protocols, and validation activities to meet project timelines
• Optimise quality processes for efficiency while maintaining compliance with medical device regulations
• Manage key quality system processes, including CAPAs, internal audits, NCRs, and Supplier Quality systems
• Support external audits and collaborate with cross-functional teams to ensure alignment on quality and compliance goals
• Provide training on risk management, process controls, and quality best practices to reinforce a quality-driven culture
• Travel (10-40%) to support quality initiatives and maintain a strong on-site presence at our various contract manufacturers

Qualifications:

• Bachelor’s degree in engineering or related field
• Minimum of 5+ years in the medical device industry, with at least 2 years in a quality-focused role