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Ingénieur(e) Validation – F/H

Présentation société

At AcuSurgical, we are shaping the future of ophthalmic surgery with a focus on advanced robotic solutions for vitreoretinal procedures. Founded in 2020, in Montpellier, France, we are driven by a clear mission: to empower surgeons with tools that enhance precision, improve outcomes, and address the complex challenges of ophthalmic surgery.

We are seeking a talented Validation Engineer to join our QA team and contribute in the implementation
of systems validation projects and initiatives in the development and manufacturing of robotic surgical
devices to deliver robotic solutions that enhance patient care, ensuring effectively establishing and meeting
validation and process development requirements.
This is an exciting opportunity to make a significant impact in a startup environment where your work will
directly shape our product and company direction

As a member of the QA team and under the supervision of the Quality Assurance and Regulatory Affairs
Director, the missions are:
• Manage validation project timelines, resources, and deliverables.
• Ensure validation activities (e.g. software, equipment, processes) to comply with applicable
regulations (e.g., GMP, GAMP 5, 21 CFR Part 820, ISO 13485), notably VMP, Validation plan and
report, risk assessment (FMEA), test protocols.
• Implement validation projects with Subject Matter Experts (SMEs), e.g. production, incoming, D&D,
quality.
• Participate in change control, deviation management and CAPA activities.
• Provide guidance to company staff on validation principles.
• Coordinate the calibration of measuring equipment.
• Support internal and external audits, if required.

Descriptif du profil

Education & Experience
• Bachelor of Science, Engineering, or related subject with 3 to 5 years of experience in GMP
validation.
• Fluent in English.
Technical Skills
• Proficiency in Validation and QA in Medical Device or Pharmaceutical industry is needed, expertise
in validation methodologies (FMEA, IQ/OQ/PQ, CSV, process validation).
• Experience with GAMP 5 principles for computerized systems validation.
• Previous experience in ERP validation is a plus.
• Being able to understand engineering and machine tool fundamentals.
• Understanding of statistical techniques, in particular statistical sampling plans, Process Capability,
Gauge R&Rs.
Personal Qualities
• Strong problem-solving skills and attention to detail
• Ability to work independently and take ownership of projects
• Excellent communication skills and ability to work in a collaborative team environment
• Adaptability and willingness to learn new technologies quickly
• Interest in medical technology and improving patient care
• Comfort working in a fast-paced startup environment

Postuler

ABID Basma
hr@acusurgical.com