Quality Engineer I — Medical Devices | Quality & Compliance

Medtronic; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Incentive plan

Medical benefits

Job summary

Medtronic is seeking a Quality Engineer I to support product development, manufacturing, and lifecycle activities by ensuring compliance with quality systems and regulatory requirements. The role emphasizes critical thinking and data‑driven root cause analysis to support investigations, identify systemic issues, and implement effective CAPA actions.

Responsibilities include executing quality processes, reviewing and maintaining documentation, and supporting audits, validations, and risk

Qualifications

• Requires a Baccalaureate degree and 0 years relevant experience.
• Engineering Degree Required.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Implements inspection and testing and conducts statistical analysis to assess compliance and costs of nonconforming materials.
• Ensures corrective actions meet reliability standards and documentation complies with requirements.
• Specializes in areas applicable to product or process quality such as design, incoming materials, production control, and reliability.

Skills

Quality Assurance

Root Cause Analysis

CAPA

Data Analytics

Regulatory Knowledge

Education

Bachelor's Degree

Tools

Minitab

Python

Job description

Medtronic is seeking a Quality Engineer I to support product development, manufacturing, and lifecycle activities by ensuring compliance with quality systems and regulatory requirements. The role emphasizes critical thinking and data‑driven root cause analysis to support investigations, identify systemic issues, and implement effective CAPA actions.

Responsibilities include executing quality processes, reviewing and maintaining documentation, and supporting audits, validations, and risk