Quality Engineer II

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

The Quality function partners across manufacturing, operations, engineering, and quality systems to ensure products and processes meet regulatory requirements, quality standards, and business objectives. This team provides quality oversight throughout the product lifecycle, supporting risk management, process improvements, product disposition, change management, validation activities, and continuous compliance initiatives. This position is based in Juncos, Puerto Rico and follows an onsite work arrangement, requiring regular presence at the manufacturing facility to support daily operations and cross-functional collaboration.

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

• Develop, implement, and maintain quality standards, procedures, and inspection protocols for materials, components, and finished products.
• Partner with engineering and manufacturing teams to ensure quality requirements are integrated into products and production processes.
• Design and implement inspection, testing, and evaluation methods to verify product quality and process performance.
• Perform quality assurance activities, including data analysis and statistical evaluations, to identify trends and drive improvements.
• Investigate nonconformances and quality issues, determine root cause, and support implementation of corrective and preventive actions.
• Ensure quality records, investigations, and supporting documentation comply with applicable regulatory and quality system requirements.
• Provide oversight and support for production equipment qualification and process validation activities.
• Collaborate with cross-functional teams to improve product reliability, process capability, and overall quality performance.

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Required Knowledge and Experience:

• Bachelor's degree in Engineering and 2+ years of experience in Quality Engineering, Manufacturing, Engineering, or a regulated industry environment OR Master's degree.
• Experience supporting quality systems within a manufacturing or regulated environment.
• Experience conducting investigations, root cause analysis, and corrective and preventive action activities.
• Experience with quality data analysis and statistical evaluation methods.
• Knowledge of process validation, equipment qualification, or product quality control activities.

• Knowledge of Good Manufacturing Practices (GMP), FDA regulations, ISO 13485, and Quality System Regulations (QSR).
• Experience supporting Corrective and Preventive Action (CAPA), Nonconformance Material Report (NCMR), and root cause investigation activities.
• Experience using statistical analysis and quality improvement tools such as Minitab, Statistical Process Control (SPC), and trend analysis.
• Knowledge of manufacturing process controls, inspection methods, process capability, and product quality monitoring.
• Experience with electronic quality management systems (eQMS), quality data analytics, and continuous improvement methodologies.
• Lean Six Sigma Green Belt certification or experience applying Lean and Six Sigma principles in a manufacturing environment.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.