Quality Assurance Senior Specialist (RE-33739207)

Top American Medical Device company with wide portfolio of products

Responsibilities

• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders and interacts with various teams to ensure corrective and preventative actions are taken
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
• May represent QA as a single point of contact and provide QA guidance for clinical studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams
• Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
• Provides training and mentorship to less experienced members of QA staff. Ensures the work climate/culture within QA, exemplifies leadership behaviors.

Experience/Qualifications

• Experience of 3+ years in Quality Assurance at Medical Device company
• Experience of class III+ preferred
• Bacholers degree or above