Senior Quality Engineer, Manufacturing Location: 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. We value diversity and encourage applicants from all backgrounds to join us in our mission. 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. 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.
Lead risk management activities, including development and maintenance of risk management files (e.g., 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
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 in qualification and validation of manufacturing processes
Working knowledge of quality and reliability concepts, supplier management, and general manufacturing operations
Proficiency in risk management and conducting FMEAs
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:
Industry experience in medical devices strongly preferred
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.
Competitive salary and options
Professional development support and training opportunities.
Flexible working hours and travel opportunities (We have sites in Australia, UK and US!)