Quality Engineer II

Regulatory Jobs; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Medtronic in Puerto Rico is seeking a Quality Engineer to join the Quality function, partnering with manufacturing, operations, engineering, and quality systems to ensure products and processes meet regulatory requirements and quality standards.

This onsite role at the Juncos facility supports daily operations, data analysis, investigations, CAPA, and process validation activities while driving continuous improvement and compliant product quality.

Qualifications

• Bachelor's degree in Engineering with 2+ years in Quality Engineering or regulated environments.
• Experience supporting quality systems in manufacturing or regulated settings.
• Experience with investigations, root cause analysis, and CAPA.
• Experience with quality data analysis and statistical evaluation.
• Knowledge of process validation, equipment qualification, or product quality control.

Responsibilities

• Develop, implement, and maintain quality standards, procedures, and inspection protocols for materials, components, and finished products.
• Partner with engineering and manufacturing teams to integrate quality requirements into products and processes.
• Design and implement inspection, testing, and evaluation methods to verify quality.
• Perform quality assurance activities, including data analysis and statistical evaluations.
• Investigate nonconformances and root causes to support corrective and preventive actions.
• Ensure quality records and documentation comply with regulatory and quality system requirements.
• Provide oversight for equipment qualification and process validation.
• Collaborate with cross-functional teams to improve reliability and quality performance.

Skills

Quality Engineering

GMP

Regulatory compliance

Data analysis

CAPA

Education

Bachelor's degree in Engineering

Master's degree

Tools

eQMS

Statistical analysis

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.

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.

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.

Preferred Qualifications

• 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.

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 meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.