Production Quality Specialist

About The Position

Aidoc is recruiting a Production Quality Specialist in Tel Aviv. Join our team!

About Aidoc

Aidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes. Built on Aidoc’s exclusive aiOS, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Aidoc AI is always on, running in the background to change the foreground.

Our solutions are used in more than 1,000 hospitals, including leading health systems in the US. Funded by some of the industry’s leading VC’s, Aidoc has raised more than $250 million to date, and was chosen as one of TIME’s 50 most genius companies.

About this role

The Quality team at Aidoc is responsible for defining quality processes related to the development, release, and servicing of Aidoc’s products, in light of medical device and quality management standards and regulations.

The team’s role is to ensure Aidoc complies with applicable standards and regulations, while strengthening the company’s processes and products’ quality.

Responsibilities

The Production Quality Specialist is a key role, collaborating with the Delivery and R&D departments to ensure the quality and compliance of post-production activities.

Process Definition and Management: Define post-production processes, including configuration management, deployment, servicing, and infrastructure-related changes.
Compliance Assurance: Ensure all processes and associated records adhere to ISO 13485 and other relevant Quality Management System (QMS) standards and regulations.
Quality Principle Implementation: Implement critical quality management principles, such as risk management and traceability.
Record Review: Review process outputs (records) to verify compliance with established company processes.
Audit Support: Support and prepare the company for both internal and external audits.
Requirements
At least 3 years of experience as a QA/Support/Project Manager in a SaMD company.
Bachelor’s degree in Life/Exact Science/Engineering/Quality Assurance or related fields.
Exceptional process engineering skills.
Strong knowledge of FDA requirements, MDR regulation, ISO 13485, ISO 62304, ISO 14971 and IEC 62366 - an advantage.
Structured thinker with the ability to drive cross-functional projects to completion.
Ability to work independently with minimal supervision
Detail-oriented, proactive, and accountable.
Strong communication skills in English, both written and verbal.
Collaborative, team-oriented mindset with a passion for learning and growth.
Working at Aidoc

Our Perks:

Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives)
We work in a hybrid model, with our new offices located at 34 HaMasger Street in Tel Aviv and parking for employees.
Amazing and healthy breakfasts and lunches prepared daily by our personal chef!
Stocked up kitchen & meal card
Wellness: Aidoc employees-only gym, plus Pilates, Yoga, and functional workouts classes.
Amazing culture - collaborative, transparent & fun!
Attractive compensation package & benefits