Job Description

Main Missions:

The Senior Quality Assurance Specialist is pivotal in designing, implementing, and maintaining the company’s Quality Management System (QMS). This individual ensures compliance with policies, procedures, and regulatory standards while driving continuous improvement to meet customer expectations. Acting as a key partner to management, they foster a strong quality culture across the organization and actively contribute to internal and customer audits to ensure adherence to quality standards.

Key Roles and Responsibilities:

Design and Maintenance of the QMS:

• Contribute to defining the Group’s quality standards and objectives.
• Coordinate the drafting and validating QMS policies and procedures in collaboration with management.
• Manage and maintain QMS documentation.
• Ensure the QMS aligns with organizational needs and customer requirements.
• Develop and implement QMS monitoring tools.

Implementation of Policies and Procedures:

• Communicate QMS policies and procedures effectively to stakeholders.
• Organize and facilitate necessary training programs to ensure understanding and compliance.
• Oversee the Training Process and identify opportunities for improvement.
• Continuously enhance the QMS to align with evolving business needs and best practices.

Process Compliance and Incident Management:

• Identify, investigate, report, and manage quality incidents.
• Collaborate with managers to define and implement corrective and preventive actions (CAPAs).
• Monitor QMS deviations and ensure timely resolution.
• Document compliance activities and report on action plans to the VP of Global Operations.

Licensing and Certification Management:

• Coordinate the application and renewal of operational pharmaceutical licenses and certifications.
• Manage related documentation to maintain compliance.

Audit Participation:

• Participate in internal audits to identify gaps and monitor corrective actions.
• Organize and coordinate customer audits, including preparation, key personnel involvement, and follow-up on findings and action plans.

Supplier Management:

• Support selecting and evaluating suppliers impacting the QMS and Good Clinical Practices (GCP).
• Conduct supplier audits and performance evaluations based on risk analysis.

Client Qualification Process:

• Coordinate responses to client RFIs (Requests for Information).

Promotion of Quality Culture:

• Advocate for a quality-driven mindset within the organization.
• Actively market QA initiatives and foster team engagement in quality practices.

Profile Requirements:

• Bachelor’s degree in Quality, Safety, and Environment (QSE), Biomedical Engineering, or a related field.
• Proven experience in the medical sector with QMS, QA, and internal auditing responsibilities.
• Fluency in English (French or additional foreign languages is a plus).
• Proficiency in computing systems and QMS tools.
• Strong communication, organizational, and teamwork skills with an autonomous and results-oriented approach.

Objectives & KPIs:

• On-Time, In-Full (OTIF): Delivery of QA initiatives.
• Quality Index: Measured performance against defined quality standards.
• Training Index: Completion and effectiveness of training programs.
• Audit Results: Number of critical findings during customer audits.

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