Quality Manager

Lyon  - CDI

À propos de Notre offre ProPulse by PULSALYS

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.

Description du poste

Missions: 

- 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.

Description du profil

- 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.


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