Quality Assurance Engineer
1 week ago
At Medtronic, we are committed to accelerating and advancing our ability to create meaningful innovations. As a Senior Quality Engineer, you will be a key member of our quality engineering team responsible for maintaining the highest standards of product reliability and patient well-being through precise risk assessment and management.
A Day in the Life:
- You will collaborate with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards.
- You will serve as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.
- You will ensure compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
- You will review Design History Files and Technical Files to ensure alignment with applicable requirements.
- You will deliver presentations on project status and issues to the QA organization and provide training to other departments on relevant procedures and policies.
- You will participate in audits and demonstrate the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
Required Skills and Qualifications:
- 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
- Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- Good verbal and written communication skills
About Us:
Together, we can change healthcare worldwide. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Salary Range: $100,000 - $140,000 per year
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