Healshape is a company created in January 2020 developing personalized & natural products for breast surgery. Healshape is actually developing these products based on 3D bioprinting and allowing patient’s own tissue regeneration, which are a medical device class 3 and an Advanced Therapy Medicinal Product.
Healshape is today composed of 6 associates providing skills and experience in business, 3D printing, tissue engineering, regulatory and surgery as well as a research engineer.
The job will take place in Healshape’s lab located on Doua Campus, in Villeurbanne.
- Implement a quality assurance program for the design and production compliant with ISO 13485 and QSR (21 CFR Part 820).
- Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations along products’ development (product design, conception...).
- Assure robust product vs. customer requirements.
- Identify risks and build robust appropriate risk mitigation plan.
- Support elaboration of development plan.
- Ensure proper documentation is in place.
- Take part to project meetings and formalize the minutes.
- Perform 3rd party supplier management activities, provide input to quality agreements.
- Manage the internal audits of the Quality System.
- Provide consultation & training on specific QA expertise.
- Responsible for implementation and compliance with company policies and procedures.
- Bachelor’s Degree in field relating to engineering, manufacturing, or quality.
- Minimum of 4 years’ experience in a manufacturing environment, preferably related to the medical device or drug development field.
- Able to manage multiple priorities with many time constraints.
- Knowledge of ISO-13485, GMP and FDA Regulations.
- Excellent communications and organizational skills.
- English and French speaking.
- Autonomous and taking initiatives.
- Looking forward to taking part to a disruptive project from the start.
- Start-up mindset.
Quick availability will be appreciated.