Senior Supplier Quality Engineer

MED Medtronic Inc; Irvine, Toledo (CA, OH); On-site; USD 99,000 - 149,000; Full time

Benefits offered by this job

Health insurance

Dental and vision insurance

Health Savings Account

Flexible Spending Account

Life insurance

Long-term disability leave

Tuition assistance/reimbursement

Job summary

Medtronic is seeking a Supplier Quality Engineer based in Irvine, CA. You will partner with suppliers and cross‑functional teams to ensure purchased materials meet quality and regulatory requirements throughout the product lifecycle, supporting supplier qualification, new product development, and process improvements.

The role involves leading supplier qualification, conducting audits, investigating nonconformances, and driving CAPA with focus on quality, delivery, and reliability, plus travel

Qualifications

• Bachelor's degree with 4+ years in supplier quality or related field.
• Experience leading investigations and corrective actions for quality issues.
• Experience in regulated quality systems and compliance requirements.
• Experience collaborating with cross‑functional teams and external suppliers.

Responsibilities

• Lead supplier qualification and onboarding activities including audits and approvals.
• Drive investigation, root cause analysis and CAPA for quality issues.
• Partner with R&D, Manufacturing, Operations Quality and Sourcing on new product introductions and design changes.
• Monitor supplier quality performance with metrics and drive continuous improvement.
• Conduct supplier audits and assessments to ensure regulatory and quality system compliance.

Skills

Supplier quality

Quality engineering

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

APQP

PPAP

FMEA

SPC

MSA

DOE

Job description

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 Neurovascular Operating Unit develops technologies that support minimally invasive treatment of stroke and other neurovascular conditions. Supplier Quality Engineering plays a critical role in ensuring externally sourced materials, components, and services consistently meet quality, regulatory, and business requirements while supporting product reliability and supply continuity.

This position is based in Irvine, California and supports manufacturing, research and development, operations quality, and sourcing teams within the Neurovascular business. The role is onsite five days per week and requires collaboration with internal stakeholders and external suppliers to support supplier qualification, performance monitoring, new product introductions, and process improvements. Travel to supplier locations may be required for audits, assessments, and supplier development activities.

As a Supplier Quality Engineer, you will partner with suppliers and cross‑functional teams to ensure purchased materials and components meet quality and regulatory requirements throughout the product lifecycle. This role supports supplier qualification, new product development activities, supplier performance improvement, and investigation of supplier‑related quality issues that could impact product performance, manufacturing operations, or patient outcomes.

Primary Responsibilities

• Lead supplier qualification and onboarding activities, including quality assessments, audits, documentation review, and approval of new suppliers.
• Drive investigation, root cause analysis, and resolution of supplier‑related nonconformances, complaints, and material quality issues.
• Partner with Research and Development, Manufacturing, Operations Quality, and Sourcing teams to support new product introductions, design changes, and supplier transfers.
• Monitor supplier quality performance using established metrics and drive corrective and preventive actions to improve quality, delivery, and reliability.
• Support risk management activities for supplied materials, components, and manufacturing processes, including risk assessments and mitigation plans.
• Collaborate with engineering teams to develop inspection strategies, control plans, test methods, and qualification requirements for new products and components.
• Conduct supplier audits and assessments to evaluate compliance with quality system, regulatory, and operational requirements.
• Support validation, qualification, and continuous improvement activities at supplier sites to ensure consistent product quality and process performance.

Required Qualifications

• Bachelor's degree and 4+ years of relevant experience, Master's degree and 2+ years of relevant experience, or PhD.
• Experience in supplier quality, quality engineering, manufacturing quality, or a related quality‑focused engineering function.
• Experience leading investigations, root cause analysis, and corrective action activities for quality issues.
• Experience working within a regulated quality management system and applying quality and compliance requirements.
• Experience collaborating with cross‑functional teams and external suppliers to resolve quality and process issues.

Preferred Qualifications

• Experience in the medical device industry or other highly regulated industries operating under applicable regulatory and quality standards.
• Experience supporting new product development, design transfer, supplier development, or supplier qualification activities.
• Experience conducting supplier audits and implementing supplier corrective action or corrective and preventive action programs.
• Knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), Measurement System Analysis (MSA), Design of Experiments (DOE), or process validation methodologies.
• American Society for Quality certifications such as Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or Six Sigma Green Belt or Black Belt certification.
• 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

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

Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00

This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health
• Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long‑term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well‑being program)

The following benefits and additional compensation are available to all regular employees:

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short‑term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

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.

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.