Quality Engineer I

Medtronic • Humacao, PR

23h

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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. A Quality Engineer I supports 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 corrective and preventive actions. Responsibilities include executing quality processes, reviewing and maintaining documentation, and supporting audits, validations, and risk management activities. The Quality Engineer I works cross‑functionally to proactively identify quality risks, drive continuous improvement, and ensure products consistently meet internal and external requirements. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Requirements

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

Nice To Haves

• Working knowledge of Manufacturing Execution Systems (MES) to support manufacturing controls, data integrity, and investigations
• Understanding of Quality Management Systems (QMS), including document control, nonconformance management, CAPA, and change management
• Familiarity with regulatory standards and requirements (e.g., FDA QSR, ISO 13485)
• Experience with data analytics and statistical analysis to support quality investigations and continuous improvement
• Exposure to Six Sigma / Lean methodologies, including DMAIC problem‑solving framework
• Hands-on experience using statistical software such as Minitab or similar tools for trend analysis, capability studies, and root cause evaluation
• Basic programming or scripting experience (e.g., VBA, Python, or similar) to automate data analysis or reporting
• Experience applying root cause analysis tools (5 Whys, Fishbone, FMEA) in manufacturing or quality environments
• Strong critical thinking, problem‑solving, and cross-functional collaboration skills
• Industrial, Mechanical or Electrical Engineering Degree
• COOP or Capstone experience in Medical Devices industry.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees