Senior Specialist QA & PMS

Work Flexibility

• The source states that the work arrangement may be hybrid or onsite.

Role Overview

Quality and Compliance Responsibilities

• Execute Quality Assurance and Post Market Surveillance activities under local, regional, and corporate procedures and requirements.
• Support the local Quality Management System and ongoing regulatory compliance.
• Coordinate product safety reporting with healthcare professionals, distributors, regulatory authorities, and other stakeholders.
• Manage quality events including non-conformances, corrective and preventive actions, and follow-up activities.
• Develop, update, and implement quality procedures, work instructions, and standard operating procedures.
• Participate in internal and external audits and support inspection readiness.
• Deliver quality and compliance training and support onboarding of new team members.
• Integrate quality requirements into business processes and support regional or global quality system changes.
• Monitor and report quality metrics, support continuous improvement, and promote a culture of quality and compliance.
• Collaborate with EEMEA and global RAQA teams on business and regulatory objectives.

Requirements

• The source begins a requirements section but ends before the qualifications are provided.
• The role requires support for Quality Assurance, Post Market Surveillance, quality systems, regulatory compliance, reporting, audit, and quality event activities based on the stated responsibilities.