Sr Quality Engineer

PRC Medtronic PR Operations Co.; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Medtronic in Puerto Rico seeks a Senior Quality Engineer to lead quality initiatives in a regulated manufacturing setting. You will drive CAPA programs, partner with engineering and manufacturing to elevate product and process quality, and apply robust data analysis to improve reliability and compliance.

The role requires collaboration across teams, strong problem-solving, and mentoring junior engineers while maintaining GMP, FDA, and ISO 13485 standards in daily operations.

Qualifications

• Bachelor's in Engineering with 4+ years in quality engineering in a regulated manufacturing environment.
• Experience conducting investigations, assessing nonconformances, and implementing corrective actions.
• Proficiency with statistical methods and data analysis to evaluate product/process performance.
• Ability to collaborate with cross-functional teams including engineering, manufacturing, and quality.

Responsibilities

• Lead CAPA, NCMR, and root cause investigations to identify systemic issues and implement corrective actions.
• Partner with engineering/manufacturing to establish and improve product and process quality standards.
• Develop and maintain quality protocols, procedures, and inspection strategies for manufacturing processes.
• Design and execute inspection, testing, and evaluation methods to verify product quality.
• Apply SPC, trend analysis, and data analytics to monitor performance and drive decisions.
• Support GMP, FDA, ISO 13485 compliance and internal procedures.

Skills

Quality engineering

CAPA investigations

Statistical analysis

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

PhD

Tools

Minitab

SPC

Job description

A Day in the Life

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.

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

Equal Employment Opportunity

Medtronic is committed to providing 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.

Equal Employment Opportunity (duplicate)

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.

Company Culture and Mission

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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.

Other Compliance Information

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

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