Sr Quality Engineer

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

Job summary

Medtronic Humacao, Puerto Rico is seeking a Senior Quality Engineer to lead quality for machining, anodizing, and final pack, ensuring processes and documentation meet GMP, FDA, ISO requirements.

You will partner with Manufacturing, Engineering, Supply Chain and Quality to drive investigations, CAPA, and process validation, enabling product launches and sustained excellence in a regulated medical-devices environment.

Qualifications

• Requires a Bachelor's degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• Engineering Degree required
• Experience in regulated manufacturing environments (medical devices, pharma) is preferred.
• Knowledge of quality system expectations (document control, CAPA, change control, audit readiness).
• Ability to support manufacturing quality activities, investigations, validation deliverables, risk assessments, and monitoring.

Responsibilities

• Lead quality engineering for machining, anodizing, and final pack.
• Ensure GMP, FDA, and ISO compliance through documentation and traceability.
• Support nonconformance, CAPA, investigations, and audit readiness.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Quality for product launch and sustained quality.
• Develop and apply inspection, testing, validation, and process evaluation methods.
• Apply statistical analysis to evaluate process capability and investigate out-of-spec products.

Skills

Quality engineering

GMP

CAPA

Documentation

Process validation

Audit readiness

Risk management

Statistical analysis

Regulatory

Quality systems

Education

Engineering degree

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

Onsite

Humacao, Puerto Rico, United States of America

Full time

R70467

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 Senior Quality Engineer provides quality engineering leadership for machining and selected secondary operations, including anodizing and final pack. This role ensures product and process quality by partnering with cross-functional teams to confirm that manufacturing processes, equipment, components, and documentation meet regulatory requirements, and Medtronic Quality Management System expectations.

The role drives compliance with GMP, FDA, and ISO requirements through disciplined documentation, traceability, investigation support, and audit readiness. The Senior Quality Engineer also strengthens product and process robustness by analyzing data, identifying quality risks, supporting nonconformance and CAPA activities, and collaborating with Manufacturing, Engineering, Supply Chain, and Quality partners to enable successful product launch and sustained

A Day in the Life

Partner with Manufacturing, Process Development, and Engineering teams to define, implement, and sustain effective quality controls for machining and secondary manufacturing processes.

Develop and implement inspection, testing, validation, and process evaluation methods to ensure equipment, components, and products consistently meet established requirements.

Apply statistical analysis and quality engineering tools to evaluate process capability, support component and process qualification, and investigate products, materials, or processes that do not meet specifications.

Ensure investigations, corrective actions, validations, and supporting documentation are compliant, technically justified, risk-based, and inspection-ready.

Lead or support product lifecycle quality activities, including process quality, incoming materials, product evaluation, validation, change management, and continuous improvement.

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 Bachelor's degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Engineering Degree required

Must Have: Minimum Requirements

• Education: Bachelor’s degree in engineeringrequired.
• Experience: Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or amaster’s degree in engineeringwith a minimum of 2 years of relevant experience.
• Regulated manufacturing: Experience working in a regulated manufacturing environment, preferably medical devices, pharmaceutical, or other highly controlledindustry.
• Quality systems: Working knowledge of quality system expectations, including documentation, nonconformance handling, corrective and preventive actions, change control, and audit readiness.
• Technical execution: Ability to support manufacturing process quality activities, investigations,validationdeliverables, risk assessments, and product/process performance monitoring.

Nice to Have

• Education discipline: Preferredbachelor’s ormaster’s degree in Mechanical, Industrial, Electricalengineering.
• Medical device experience: Experience in medical device or other FDA/ISO-regulated manufacturing environment, including GMP expectations and inspection readiness.
• Quality systems: Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management.
• Validation: Knowledge of equipment, process, product, and software validation concepts, including URS, SRS, IQ, OQ, PQ, risk-based validation, andimplementationreadiness.
• Manufacturing process knowledge: Experience supporting machining, anodizing, final pack, inspection, test methods,componentqualification, or other manufacturing process controls.
• Problem solving and risk: Experience applying root cause analysis and risk assessment tools such as 5 Whys, Fishbone, FMEA, fault tree analysis, or similar structured methods.
• Data and statistics: Experience using SPC, capability analysis, DOE, trending, sampling rationale, or statistical methods to support investigations, process monitoring, and continuous improvement.
• Digital tools: Hands-on experience with Minitab, JMP, Excel advanced functions, Power BI, PowerPoint, SAP, JDE, Factory Works, or similar systems used for data analysis, reporting, traceability, and manufacturing execution.
• Continuous improvement: Lean Six Sigma Green Belt, Black Belt, or equivalent training/certification preferred.
• Technical writing: Demonstratedability to write clear, technically sound, and audit-ready protocols, reports, investigations, justifications, and quality documentation.
• Leadership and collaboration: Strong critical thinking, communication, prioritization, and cross-functional collaboration skills in a fast-paced manufacturing environment.
• Automation and AI enablement: Experience with data extraction, automation, dashboards, or basic programming tools such as VBA, Python, Copilot, ChatGPT, Gemini, or similar applications to improve reporting and process analysis.

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

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.

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 (https://www.e-verify.gov/employees) .

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