Senior Quality Engineer - Remote

Overview

As a Senior Quality Engineer at Medtronic, you will be a key member of the Post Market Quality Engineering team, responsible for maintaining the highest standards of product reliability and patient well-being through data analysis, report writing, and communication with regulatory agencies.

In Short

• Collaborate with cross-functional teams to analyze data related to medical device performance and safety.
• Partner with regulatory affairs to ensure timely submission of PSURs.
• Monitor evolving safety regulations for PSUR compliance.
• Develop templates and training based on quality system regulations.
• Review deliverables for compliance with development processes.
• Deliver presentations and training to the QA organization and other departments.
• Hands-on experience with EU MDR and risk management.
• Familiarity with ISO 13485, ISO 14971, and other industry standards.
• Experience in collaborating with regulatory teams for safety report submissions.
• Minimum 5-8 years of quality engineering experience required.

Requirements

• B.E or B.Tech in Mechanical/Biomedical Engineering.
• Understanding of post-market surveillance processes.
• Knowledge of risk management principles in medical devices.
• Familiarity with ISO 9001, 21 CFR part 820, and 21 CFR part 11.
• Good verbal and written communication skills.
• Experience with FDA Quality System Regulation.
• Hands-on experience with DMAIC or DMADV methodologies.
• Ability to work in a cross-functional team environment.
• Experience in audits related to quality systems.
• Strong analytical and problem-solving skills.

Benefits

• Competitive salary and flexible benefits package.
• Commitment to employee well-being and career development.
• Access to a wide range of resources and support.
• Opportunities for lifelong learning and growth.
• Inclusive culture that values diverse perspectives.