Senior Manufacturing Quality Engineer - temporary position (1-year contract)

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 Life As a Senior Manufacturing Quality Engineer , you will play a key role in ensuring that products are manufactured in compliance with internal quality standards, regulatory requirements, and Medtronic’s commitment to patient safety and product excellence. This position partners closely with Manufacturing, Operations, R&D, and Supply Chain to drive quality improvements and support continuous improvement initiatives on the production floor. This is a temporary, 6-month contract role responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices. Primary Responsibilities: Maintain and continuously improve the Quality Management System in compliance with ISO 13485, EU MDR, and FDA QSR (21 CFR 820) Support Operations activities, including manufacturing, validation, MRB, CAPA. Oversee CAPA, nonconformances, deviations, complaints, risk management, change controls, document control, and training processes. Actively participate in and support internal and regulatory audits, including preparation, execution, and follow-up. Collaborate cross-functionally with R&D, Regulatory Affairs, Operations, and Supply Quality teams. Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements. Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions. Required Qualifications: Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related field. 7+ years of QA production experience within the medical device industry. In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR. Hands-on experience with ECO’s, nonconformance management, CAPA, and root cause analysis tools. Strong communication skills in English, both written and verbal. Preferred Qualifications: Knowledge of Lean, Six Sigma, or continuous improvement methodologies. Ability to work effectively in a cross-functional, fast-paced manufacturing environment. 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. ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at . 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).