Medical Device Quality Manager
Limbus AI is a privately held software company that develops medical products designed to improve efficiency in cancer diagnosis, treatment, and follow up.
We specialize in developing state of the art machine learning algorithms trained on a world class proprietary database of expert validated medical images.
Our main product utilizes machine learning models to perform accurate and fast segmentation of organs at risk - a critical component of radiotherapy treatment planning.
We’re a small team: a radiation oncologist, a medical physicist, and two engineers. We’re looking for a smart, energetic, and self-motivated individual who wants to get in on the ground floor of a fast-moving startup.
Regina, Saskatchewan OR remote within Canada.
Limbus AI has an immediate need for a Medical Device Quality Manager (Part-Time) experienced in the medical device industry. This is a unique opportunity to support Limbus AI in bringing a variety of medical devices and new technologies to market.
The Quality Manager (Part-Time) will be responsible for quality department management and supporting various aspects of the Quality Management System (QMS), including:
- Implementing a QMS
- Document and change control
- Record/device history records reviews
- Training program management
- Quality record management
- Change control
- Supplier quality
- Internal audit / external audit management
- Developing and measuring key quality initiatives
The position is part-time with approximately 20 hours a week on-site or remote.
Key Duties and Responsibilities:
- Manage quality at Limbus AI
- Manage the document control function and maintain all QMS records
- Write Standard Operating Procedures (SOPs)
- Support software engineering in generating development quality records
- Support R&D and product development in the design control process through clinical trials, and commercialization
- Manage the employee training program
- Manage CAPA activities
- Manage the approved supplier program
- Coordinate and manage internal audit activities, external audit activities, key quality initiatives
- Undergraduate degree in engineering, science, or other related field
- Working knowledge of GDP; FDA 21 CFR, Part 820, quality system regulations; and ISO 13485
- Working knowledge of ISO 9001 a plus
- Practical knowledge of risk management
- Exceptional organizational skills
- Excellent written and verbal communication skills
- Capable of supporting cross-functional project goals with a quality focus
- Ability to work effectively in a positive, fast-paced, start-up, team environment
- Canadian citizen / permanent resident
- Medical device experience – 1-5 years in an application requiring software medical devices
- SOP experience – 1-5 years drafting and releasing standard operating procedures
- Quality assurance/quality system experience – 1-5 years
- Knowledge of, and experience with, Software as a Medical Device (SaMD) is an important asset
Qualified candidates should submit a resume and cover letter. The cover letter should include information on your availability, and how your previous experience relates to the job requirements: specific examples are of interest. All your information will be kept confidential.Apply