Sr Quality Engineer

Medtronic; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Medtronic in Juncos, Puerto Rico, is seeking a Senior Quality Engineer to lead quality initiatives within a regulated manufacturing environment. You will partner with engineering and manufacturing to implement quality standards, drive investigations, and support continuous improvement to enhance compliance and reliability.

Key responsibilities include leading CAPA/NCMR/root-cause efforts, applying SPC and data analysis, and ensuring GMP/FDA/ISO13485 compliance.

Qualifications

• Bachelor's in Engineering with 4+ years quality experience in regulated manufacturing.
• Experience investigations, nonconformances, and corrective actions.
• Experience using statistics to evaluate process performance.
• Ability to collaborate with engineering, manufacturing, and QA teams.
• Knowledge of GMP, FDA, ISO 13485, and internal procedures.

Responsibilities

• Lead CAPA, NCMR, and root-cause investigations.
• Collaborate with engineering and manufacturing to improve quality standards.
• Develop and maintain quality protocols and inspection strategies.
• Design and execute inspection, testing, and evaluation methods.
• Apply SPC and trend analysis to monitor performance.
• Assess nonconformances and ensure corrective actions meet reliability.
• Support GMP, FDA, ISO13485 compliance and internal procedures.
• Mentor junior quality engineers.

Skills

Capable with quality engineering

Statistical analysis

Cross-functional collaboration

Root cause analysis

GMP/FDA/ISO13485 knowledge

Education

Bachelor's Degree in Engineering

Master's Degree or PhD

Tools

Minitab

SPC

Lean Six Sigma (Green/Black Belt)

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

The Quality function partners across engineering, manufacturing, and operations to ensure products and processes meet regulatory, quality, and customer requirements throughout the product lifecycle. This team drives product and process quality through quality system oversight, continuous improvement, statistical analysis, and cross-functional collaboration.
This position is based in Juncos, Puerto Rico and follows an onsite work model.

The Senior Quality Engineer is responsible for driving product and process quality initiatives within a regulated manufacturing environment. This role partners closely with engineering and manufacturing teams to implement quality standards, lead complex investigations, analyze quality data, and support continuous improvement efforts that enhance compliance, reliability, and operational performance.

Primary Responsibilities

• Lead complex Corrective and Preventive Action (CAPA), Nonconforming Material Report (NCMR), and root cause investigations to identify systemic issues and implement sustainable corrective actions.
• Partner with engineering and manufacturing teams to establish, maintain, and improve product and process quality standards.
• Develop, implement, and maintain quality protocols, procedures, and inspection strategies for manufacturing processes and products.
• Design and execute inspection, testing, and evaluation methods to verify product quality and process effectiveness.
• Apply statistical analysis techniques, including Statistical Process Control (SPC), trend analysis, and Minitab tools, to identify risks, monitor performance, and drive data-based decisions.
• Assess product and process nonconformances, determine root causes, and ensure corrective actions meet reliability, compliance, and quality requirements.
• Support quality system compliance with Good Manufacturing Practices (GMP), U.S. Food and Drug Administration (FDA) regulations, ISO 13485 requirements, and internal procedures.
• Mentor and coach junior Quality Engineers while promoting a culture of quality and continuous improvement across the site.

Required Qualifications

• Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience; OR Master's Degree and a minimum of 2 years of relevant experience; OR PhD.
• Experience supporting quality engineering activities within a regulated manufacturing environment.
• Experience conducting investigations, assessing nonconformances, and implementing corrective actions.
• Experience using statistical methods and data analysis to evaluate product or process performance.
• Ability to collaborate effectively with cross-functional teams including engineering, manufacturing, and quality organizations.

Preferred Qualifications

• Advanced knowledge of Good Manufacturing Practices (GMP), U.S. Food and Drug Administration (FDA) regulations, ISO 13485, and Quality System Regulations.
• Experience leading complex CAPA, NCMR, and root cause investigations.
• Expertise with Minitab, Statistical Process Control (SPC), trend analysis, and process capability assessments.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with manufacturing process controls, inspection optimization, digital quality systems, and quality data analytics tools.

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 findhere a list of all material job duties of the specific job position which Medtricon 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.