Clinical Quality Consultant Zaventem (BE) • Oxford Global Resources

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Our client, a leading global medical devices company, is looking for a Clinical Quality Consultant to come on board and join their team.
You will be working with Clinical Affairs organization process owners to support all Clinical Quality CAPA activities: understanding Quality System Processes, Procedures, and tools to ensure compliance with applicable US and International standards and regulations. You will be supporting with their Quality system projects.

Key Responsibilities:

Provides maintenance support of the quality assurance tasks:

• Support in document control activities by reviewing changes to the procedures with Business owners
• Oversight and execution support of CAPA processes
• Supports external audits and inspections as required, support with strategic responses, as assigned.

Provides Clinical process and procedure development support by:

• Ensures compliance to applicable US and International Standards and Regulations by providing support for interpretation of GCP related regulations, performing gap analysis and lead activities to implement improvements.
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Making appropriate recommendations for continuing, modifying, or abandoning proposed projects, processes and/or systems

Provides project management support, as required

Provides GCP coaching and training support.

• Maintains relationships and communications with business and other functional areas

Requirements:

• Ideally four to five years of Clinical or Quality functional experience.
• Proficiency in GCP, ISO 14155:2020 requirements, EU MDR, 21 CRF 812, or ISO 13485, GMP, etc
• This person must have excellent communication and customer service skills and strong team motivation skills in order to manage work that requires effective delivery to internal customers.
• Detail oriented and high interest in reviewing and understanding quality system procedures
• Hands-on approach, with the ability to dive into tasks and deliver results promptly.

Contract Information:

• Start Date: ASAP (June 23rd).
• Full-time.
• 3 days/week on site in Zaventem.