Senior Supplier Quality Engineer

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

Job summary

Medtronic in Irvine, CA is hiring a Supplier Quality Engineer to ensure purchased materials and components meet quality and regulatory standards across the product lifecycle.

You will lead supplier qualification, drive root cause analyses, and partner with R&D, Manufacturing, and Sourcing to support new product introductions and supplier transfers, with on-site collaboration five days/week.

Qualifications

• Bachelor’s degree or higher in engineering or science with 4+ years in supplier quality.
• Experience in supplier quality, quality engineering, or manufacturing quality.
• Experience leading investigations and corrective actions for quality issues.
• Experience in regulated quality systems and compliance.
• Experience working with cross-functional teams and external suppliers.

Responsibilities

• Lead supplier qualification and onboarding activities, including audits and supplier approvals.
• Drive investigations, root cause analysis, and corrective actions for nonconformances.
• Partner with R&D, Manufacturing, Operations Quality and Sourcing on new product introductions and design changes.
• Monitor supplier quality using metrics and drive corrective actions to improve quality and delivery.
• Support risk management for supplied materials and processes, including risk mitigation.
• Collaborate with engineering teams to develop inspection strategies, control plans and test methods.
• Conduct supplier audits and assessments to ensure compliance with quality systems and regulatory requirements.
• Support validation, qualification and continuous improvement activities at supplier sites.

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

Process Validation

Job description

We anticipate the application window for this opening will close on - 24 Sep 2026

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 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

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.

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 pertaining 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, andSimple 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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

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.

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