Quality Engineer I

Medtronic; Humacao (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Medtronic is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life. A Quality Engineer I supports product development, manufacturing, and lifecycle activities by ensuring quality systems and regulatory compliance.

The role emphasizes data-driven investigations, CAPA, and cross‑functional collaboration to prevent defects and improve processes in a fast-paced environment.

Qualifications

• Bachelor’s degree required; 0 years of relevant experience.
• Familiarity with MES, QMS, CAPA, and change management.
• Knowledge of FDA QSR and ISO 13485 standards.
• Experience with data analytics and statistics for investigations.
• Six Sigma/Lean exposure and DMAIC problem solving.
• Minitab or similar tools for trend analysis and root cause evaluation.
• Programming or scripting (Python, VBA) to automate data analysis.

Responsibilities

• Develops, applies and maintains quality standards and protocols for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs and implements inspection and testing mechanisms; conducts statistical analyses.
• Ensures corrective actions meet reliability standards and documentation compliance.
• Supports audits, validations and risk management activities.
• Identifies quality risks and drives continuous improvement across functions.

Skills

Quality Assurance

Root Cause Analysis

Statistical Analysis

Cross-Functional Collaboration

Regulatory Knowledge

Data Analytics

Education

Bachelor's degree

Tools

Minitab

Python

VBA

QMS software

Job description

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.

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.

Required Knowledge and Experience:

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

Nice to Have Qualifications

• 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.

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.

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.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a