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.
• 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.
We are looking for
• MS in related field plus 2+ years of QA experience, BS/BA in technical field with plus 4+ years’ experience.
• Demonstrated knowledge & expertise on subjects mentioned below but not limited to:
o ISO Standards (i.e., 13485, 14971, 14001)
o US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD)
o Medical Device Design Control Requirements
• Lead / Internal Auditor Training
• Excellent Communication
• Excellent QA/Regulatory Writing Skills in English
• Proficient in Microsoft and other organizational tools
• Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts
Best, the Netherlands.