San Diego, US
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Quality Engineer - Site based at our sites in San Diego
Permanent / Full time
The Quality Engineer provides leadership of quality assurance for the LumiraDx molecular diagnostics and protein reagent businesses located in San Diego, CA and Solana Beach, CA. Responsible for new product development and operational quality activities. Reporting to the Director Quality, the Quality Engineer will work collaboratively as part of the LumiraDx San Diego quality team as well as interact with other internal and external departments.
- Responsible for maintaining quality assurance of manufacturing and associated processes for LumiraDx San Diego and Solana Beach facilities within the scope of the business, including new product development, manufacturing, and post-market quality responsibilities.
- Perform data analysis to monitor Manufacturing and Post Market performance and compliance. Ensure trending is performed and provided to management team as scheduled. Responsible for providing feedback from manufacturing operations and complaints processes to process owners for continuous improvement.
- Provide quality input and support for new product development, lead risk management plans, hazard reports, risk analysis, and risk reports.
- Lead investigations for nonconforming materials, corrective/preventive actions, and complaints to ensure timely closure.
- Lead supplier quality initiatives including supplier corrective actions.
- Write, review, and approve validations ensuring systems utilities and processes comply with regulations and standards.
- Maintain compliance with the quality system requirements, applicable internal controls and corporate polices for Product Release and Complaints Management.
- Develop and implement statistical process controls and sampling plans.
- Lead problem solving and root cause analysis. Proactively identifies/mitigates risk.
- Drives continuous improvement of quality assurance practices.
- Performs batch record reviews and final product acceptance status decisions as needed.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:
- Bachelor’s degree in scientific or technical discipline. Advanced degree and experience with in vitro diagnostics (IVD) is highly preferred.
- Relevant experience with increasing responsibility in medical device quality; experience with diagnostic devices highly preferred but not required.
- Knowledge of molecular diagnostics and protein chemistry is highly preferred.
- Formal training in quality and/or regulatory affairs with certification highly desirable (e.g. CQA, QSQ, RAC)
For further information and to apply for this role, please click APPLY