Quality Engineer II - Remote

Overview

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

In Short

• Contribute to Post Market Surveillance and Clinical Evaluation document writing.
• Collaborate with teams such as Quality/Reliability, Clinical Research, and Regulatory Affairs.
• Develop therapy and product knowledge for effective surveillance.
• Compile and analyze reports and safety communications.
• Participate in drafting responses to regulatory deficiencies.
• Ensure compliance with regulations and expectations of Regulatory Bodies.
• Work with minimal direction towards long-range goals.
• Proficient in medical terminology and clinical practices.
• Adapt to shifting priorities and competing demands.
• Knowledge of Good Clinical Practices and Quality Management Systems.

Requirements

• Bachelor’s Degree in Engineering, Science, or a related field.
• 2+ years of experience in Medical Writing or Quality Engineering.
• Experience in a regulated environment, preferably with medical devices.
• Ability to analyze complex issues and improve existing methods.
• Strong communication skills for stakeholder engagement.
• Detail-oriented with a focus on quality and compliance.
• Ability to work collaboratively in cross-functional teams.
• Understanding of EU MDR Regulation and Risk Management.
• Ability to meet objectives and milestones effectively.
• Adaptability to changing priorities.

Benefits

• Competitive salary and flexible benefits package.
• Commitment to employee contributions and success.
• Wide range of benefits and resources for career and life stages.
• Inclusive culture that values diversity and lifelong learning.
• Opportunities to contribute to life-transforming technologies.
• Support for personal and professional growth.
• Engagement in meaningful work that improves human welfare.
• Access to cutting-edge AI and data technologies.
• Collaborative environment focused on innovation.
• Commitment to equal employment opportunity and reasonable accommodations.