Software Quality & Risk Engineer M/F

The Software Quality & Risk Engineer permanent position is based in Meylan, (nearby Grenoble).

YOUR ROLE:

As part of Kayentis Quality & Regulatory team, you contribute to the quality and reliability of Kayentis Solutions by ensuring development activities are carried out in accordance with regulatory requirements applicable to computerized systems used in clinical investigations.

• Participate in the maintenance, continuous improvement, and training of processes related to the design and development of Kayentis Solutions and Services, including the appropriate consideration of :

-Risk management

-Validation principles and guidelines such as ISPE GAMP© 5

-Electronic records and electronic signatures requirements (21 CFR Part 11)

-IT Interfaces

• Maintain the Validation Master Plans of Kayentis Solution and Interfaces, and Kayentis business tools
• Perform a quality review of development deliverables prior to release
• Participate in the maintenance and continuous improvement of IT processes
• Maintain Kayentis risk management and validation processes. Train and Coach teams on Kayentis Quality Management System processes and applicable requirements.
• Support the following quality processes as applicable to the development and IT processes:

-Internal and client audits

-Qualification, monitoring and audits of applicable suppliers and subcontractors

-Validation of computerized systems

YOUR PROFILE:

• Master degree level or equivalent in quality, risk management, or software engineering
• Professional experience > 5 years in life science or medical technology development
• Excellent collaborative skills
• Good verbal communication and writing skills in French and English
• Customer-oriented

Preferred:

• Experience in the pharmaceutical, medical device, or clinical field
• Experience with risk management standards such as ISO14971
• Experience with GAMP© 5 guidelines or 21CFR Part 11 implementation

YOUR BENEFITS :

• Flexible working hours
• Bonuses
• Meal vouchers
• Bike allowance

Thank you for applying via rather than by email, as it ensures optimal processing of your application