Quality Engineer

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 95000 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.

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

• Assist in aligning and implementing design control processes including requirements management design reviews verification/validation and traceability.
• Support the mapping migration and harmonization of quality system processes including document control training audits and related quality activities; support internal and external audits as applicable.
• Participate in the integration and standardization of CAPA and complaints handling processes ensuring effective root cause analysis corrective and preventive actions.
• Support software development lifecycle processes including requirements management design reviews validation and testing.
• Ensure all integrated processes meet applicable regulatory requirements (FDA MDR ISOCFR Part 11 etc.) including electronic records and signatures risk analysis and audit readiness.
• Assist in updating and maintaining quality documentation provide training to stakeholders on new or revised processes identify process gaps and support continuous improvement initiatives.

Required Knowledge and Experience:

• Bachelors degree in Engineering Life Sciences or a related field.
• 3 years of experience in medical device quality engineering including QMS design controls CAPA complaints management and software validation.
• Working knowledge of FDA regulations MDR ISO 13485 and 21 CFR Part 11 requirements.
• Experience with software development lifecycle processes in regulated environments is an advantage.
• Strong analytical communication and teamwork skills with the ability to work effectively in cross-functional environments.

Experience with QMS integration or harmonization projects and electronic QMS platforms would be considered an advantage.

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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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.