Senior Quality Assurance Manager
Há 1 mês
Job Title: Senior Quality Assurance Manager
Job Description:
At Olympus Europa Se & Co. Kg, we are seeking a talented Senior Quality Assurance Manager to join our team. As a Senior Quality Assurance Manager, you will be responsible for ensuring the quality of our medical devices meets the highest standards. This will involve leading quality initiatives, developing and implementing quality systems, and ensuring compliance with regulatory requirements.
About the Role:
As a Senior Quality Assurance Manager, you will have the opportunity to work on a wide range of projects, from design transfer planning to change management. You will be responsible for providing input and leading activities related to quality systems, ensuring that our products meet the highest quality standards. You will also be responsible for leading and collaborating with global repair & service sites to create, develop, implement and maintain global quality standards and processes.
Key Responsibilities:
• Provide input and lead activities related to quality systems, ensuring that our products meet the highest quality standards.
• Lead and collaborate with global repair & service sites to create, develop, implement and maintain global quality standards and processes.
• Develop and implement innovative solutions to enhance quality outcomes.
• Develop, monitor process performance metrics, perform analysis and act upon trends with minimal guidance.
Requirements:
• Bachelor's degree in an engineering discipline (Master's preferred).
• 5+ years related experience, preferably in the medical device industry related to operations/design/quality engineering.
• Comprehensive background and knowledge with U.S. FDA QSR, requirements including ISO 13485, MDD and EU MDR, ISO 14971.
What We Offer:
• A dynamic and supportive work environment.
• Opportunities for career growth and professional development.
• A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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