Quality Assurance Engineer
3 weeks ago
Be Part of a Team that Changes Lives
We are seeking a highly skilled Sr Quality Engineer to join our team at Medtronic. As a key member of our Quality Engineering team, you will play a crucial role in maintaining the highest standards of product reliability and patient well-being.
A Day in the Life
• Collaborate with cross-functional teams to develop comprehensive product risk management files, ensuring compliance with ISO 14971 standards.
• Serve as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.
Key Responsibilities
• Conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
• Develop and maintain technical files, ensuring alignment with applicable requirements and industry standards.
• Participate in audits and demonstrate the ability to effectively contribute as a team player in various roles.
Requirements
• B.E or B.Tech in Mechanical/Biomedical Engineering
• Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience
Desired Skills
• Familiarity with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR, and product-specific industry standards.
• Good verbal and written communication skills
• Experience with statistical software tools (Minitab)
About Medtronic
We are a global leader in medical technology, driven by our mission to alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday.
Why Join Us?
At Medtronic, you will have the opportunity to work on meaningful projects, collaborate with talented professionals, and contribute to the development of innovative medical technologies.
We are committed to creating a diverse and inclusive work environment, where everyone has the opportunity to grow and succeed.
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