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

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, 1-year 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.

• 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.