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Quality Assurance Manager
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As a Quality Assurance Manager at Topcon Europe Medical B.V., you will be responsible for ensuring the high standard of product quality of Topcon's products. You will develop, implement, and maintain QA and regulatory processes, while ensuring compliance by coordinating internal and external audits. You will contribute to customer satisfaction by setting product quality standards and processes that align with customer expectations.
Key Responsibilities:
- Plan, conduct, and manage internal and external product quality audits and inspections to assess compliance with product quality standards, identify non-conformities, evaluate supplier performance, and implement corrective actions as needed.
- Assess and manage risks related to product quality, including product/process risks, regulatory risks, and supply chain risks. This includes developing risk management strategies, conducting risk assessments, and implementing risk mitigation measures.
- Define, track, and analyze key quality metrics and performance indicators (KPIs) to measure the effectiveness of product quality processes, identify trends, and make data-driven decisions for improvement.
Requirements:
- Master or Ph.D. degree in Science or Engineering
- 5+ years of experience with quality assurance of medical devices
- Excellent communication and team player skills in an international and multi-stakeholder setting
- Experience with standards and regulations such as ISO 9001, ISO 13485, FDA, EMA, GDPR
- Fluent in English (written and spoken)
What We Offer:
- An interesting and international work environment
- A varied position at a top player in the market
- A competitive reward package, including a full employer-paid pension contribution, 13th month salary, and 28 vacation days
At Topcon Europe Medical B.V., we invest in our employees and offer opportunities for growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
