
Quality Engineer, Post Market Risk Management
At Medtronic, we are dedicated to improving the lives of patients through innovative medical technology. As a Quality Engineer in our Post Market Risk Management team, you will play a crucial role in ensuring the safety and effectiveness of our products. We are seeking a highly skilled and motivated individual with a strong background in quality engineering, risk management, and medical device regulations. If you are passionate about making a positive impact on patient outcomes and have a keen eye for detail, we encourage you to apply for this exciting opportunity.
- Develop and maintain a thorough understanding of Medtronic's products, processes, and quality systems.
- Collaborate with cross-functional teams to identify and evaluate potential risks associated with Medtronic's medical devices.
- Conduct risk assessments and develop risk management plans to mitigate potential hazards.
- Monitor post-market data and complaints to identify any potential safety or quality issues.
- Investigate and analyze product failures or non-conformances to determine root cause and implement corrective actions.
- Ensure compliance with all relevant medical device regulations, standards, and guidelines.
- Develop and maintain risk management documentation, including risk management files and reports.
- Provide guidance and support to other departments on risk management principles and processes.
- Participate in audits and inspections related to risk management and quality systems.
- Continuously evaluate and improve processes to enhance product safety and effectiveness.
- Stay current on industry trends and best practices related to risk management and quality engineering.
- Communicate effectively with internal and external stakeholders regarding post-market risk management activities.
- Train and mentor other team members on risk management principles and processes.
- Serve as a subject matter expert on risk management during new product development and post-market surveillance activities.
- Uphold Medtronic's commitment to patient safety and product quality at all times.
Bachelor's Degree In Engineering Or Related Field
Minimum Of 3 Years Experience In A Quality Engineering Role, Preferably In The Medical Device Industry
Knowledge Of Post Market Risk Management Regulations And Standards, Such As Iso 14971 And Fda Guidelines
Experience With Risk Management Tools And Techniques, Including Fmea And Fault Tree Analysis
Strong Analytical And Problem-Solving Skills, With The Ability To Identify And Mitigate Potential Product Risks
Quality Assurance
Process Improvement
Data Analysis
Problem Solving
Auditing
Root Cause Analysis
Risk assessment
Regulatory compliance
Complaint handling
Product Quality
Quality Management System
Communication
Conflict Resolution
Customer Service
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Engineer, Post Market Risk Management in Los Angeles, CA, USA is $70,000 - $120,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company or industry the engineer is working in.
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Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.

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