Quality Engineer II

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the LifeCollaborating 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. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety.

Responsibilities may include the following and other duties may be assigned:

• Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
• Subject matter expert in risk management for designated medical device products or platforms.
• Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
• Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
• Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
• Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
• Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
• Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR.
• Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
• Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
• Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab)
• Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
• Independently review all deliverables to ensure compliance with development process and the standard.
• Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
• Hands-on experience on complaints analysis, Post market surveillance, Design Controls for Medical Devices.

Required knowledge and experience: 

• Bachelor’s degree in engineering, Science, or Technical Discipline required and 5-8 years of quality systems experience. Experience in post market quality is added advantage.
• Good communication skills, both oral and written.
• Comfortable working with international and multi-cultural departments and groups in different time zones.
• 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
• Understanding of post-market surveillance processes and adverse event reporting.
• Knowledge of risk management principles and hazard analysis in the context of medical devices.
  Nice to Have
• Good interpersonal skills.
• Previous experience working with global team (Aerospace, Defense, Med device, automobile preferably).
• Exposure to FDA Quality System Regulation & ISO 13485 standard.
• Quality certification – ASQ CQE, CQA and/or CSQE.
• Working knowledge of Standard, Guidance, and Regulations.
• Lean Six Sigma Yellow belt /Green Belt.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).