QA Product Release Associate

Mission

The QA product release associate ensures the final release of assigned IBA products. They ensure that released products comply with all applicable regulatory requirements and that they are safe and effective. They help to develop the quality culture across the organization by showing the added value of Quality Management integrated in IBA Clinical.

Challenges we trust you with

• Approve final release of IBA Clinical products
• Ensure QA involvement on assigned projects
• Review product & project deliverables
• Review and approve product verification and validation activities needed for final release
• Review and approve non-conformities handling decisions including follow-up of required corrections and corrective actions
• Review and approve product design change activities
• Perform in process quality audits and ensure follow-up of resulting corrections and corrective actions
• Monitor and ensure implementation of the QMS (Quality Management System) of processes and activities reviewed as part of the release activities. Support its improvement.
• Develop, maintain and improve procedures, work instructions and templates within the area of expertise
• Coach, train and assess training needs of IBA personnel on quality requirements related to release activities

What we value

You have:

• A Master's degree in Engineering/Sciences or an equivalent demonstrated by experience
• At least 2 years of work experience in a regulated environment, in a quality role
• Excellent communication skills in French and English (spoken and written)

And you also are:

• An assertive person with very good interpersonal skills
• Able to manage different projects in parallel and prioritize accordingly
• Able to work to strict deadlines and to cope with pressure
• Rigorous but don’t lose the general picture
• A hands-on and proactive person, able to find and propose collaborative solutions
• A team player
• Willing to travel worldwide (up to 10%)

Cherry on the cake

• You have working knowledge of Medical Device Regulations and ISO 13485