Senior Manufacturing Quality Engineer - temporary position (6-month 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.

• →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.

• 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.

• 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. 

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