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Your challenge
To provide Quality Assurance support and oversight to ensure compliance with Quality System and regulations that govern product development activities within the Interventional X-Ray (IXR) department.
 
Your responsibilities
· Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working
· Support New Product Introduction by providing QA technical expertise, assessments, and strategies for problem resolution & prevention
· Serve as Subject Matter Expert for quality system and design control requirements within project teams
· Participate in risk assessments and take appropriate action during QA oversight activities to ensure adequate controls in relation to level of product quality, safety and business risks.
· Review and approve Product Design Quality Records (DHF documents such as specifications, risk assessment reports, validation & verification test protocols/results/reports, etc.)
· Review and approve Corrective Actions and Preventive Actions (CAPA) in order to meet compliance requirements.
· Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation
· Accountable for interactions to enhance QA reputation within the company and to promote teamwork & understanding of quality requirements.
 

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