Senior Quality Engineer, Manufacturing
Location: Cambridge, UK (on-site)
Apply here
Opto Biosystems 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 maintaining and enhancing our quality management system, 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, and driving continuous improvement initiatives. This role demands expertise in high reliability products, strong leadership skills, and a steadfast commitment to delivering the highest quality.
Key Responsibilities:
* Lead risk management activities, including development and maintenance of risk management files (e.g., pFMEAs) in compliance with ISO 14971
* Partner with functional teams to evaluate design and processes at the concept phase
* Develop quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for incoming materials and finished devices
* Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containment
* Optimize 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
* Ensure DHF content completion, integrity, and regulatory standards compliance, collaboratively communicating and resolving gaps
* Support manufacturing in the creating, release and maintenance of DHR/LHR, bills of material, and specifications for manufacturing
* Adhere to Opto's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
* 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 a related field
* Minimum of 5+ years in manufacturing and quality control in a highly regulated industry
* Strong knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO standards related to medical device manufacturing
* Experience working with external consultants, manufacturers, and suppliers
* Experience in qualification and validation of manufacturing processes
* Working knowledge of quality and reliability concepts, supplier management, and general manufacturing operations
* Self-starter who has high levels of self-motivation, initiative, flexibility, and ability to learn and work independently
* Proficiency in risk management and conducting FMEAs
* Strong communication skills and ability to collaborate across teams
* Familiarity with relevant compliance standards and product testing requirements
* International travel is an integral part of this role. Must be eligible to obtain and maintain a work visa(s) as necessary with support from Opto.
Bonus Skills:
* ASQ certification desirable
* Advanced degree preferred
* Industry experience in medical devices strongly preferred
* Familiarity with microfabrication processes
* Hands-on experience with medical device manufacturing in a startup environment
Reporting Structure:
This role is an integral part of the quality engineering team and reports directly to the Lead Quality Engineer, with occasional guidance from the VP of Engineering.
Benefits:
* Competitive salary and options
* Professional development support and training opportunities.
* Flexible working hours and travel opportunities (We have sites in Australia, UK and US!)
* A chance to work on impactful, life-changing technologies in a dynamic, innovative environment.
If you are passionate about innovation in healthcare, we would love to hear from you! Please submit your application here.