Senior Supplier Quality Engineer

Medtronic plc; Irvine, Northern (CA, KY); Hybrid; USD 99,000 - 149,000; Full time

Job summary

Medtronic plc in Irvine, California, seeks a Senior Supplier Quality Engineer to lead supplier qualification, audits, and CAPA activities. You will partner with cross-functional teams to ensure purchased materials meet quality and regulatory standards throughout the product lifecycle, while supporting new product development and design transfers.

The role requires collaboration with R&D, Manufacturing, and Sourcing, with onsite work five days a week and travel to supplier locations as needed.

Qualifications

• Bachelor's degree and 4+ years of relevant experience, Master's degree and 2+ years, or PhD.
• Experience in supplier quality, quality engineering, manufacturing quality, or 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.

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 R&D, 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.

Skills

Supplier quality

Root cause analysis

CAPA

Cross-functional collaboration

Quality systems

Audits

Design transfer

Risk management

Regulatory compliance

Education

Bachelor's degree

Master's degree

PhD

Tools

APQP

PPAP

FMEA

SPC

MSA

DOE

Process validation

Job description

## Senior Supplier Quality EngineerPostuler: Sur site: Irvine, California, United States of America: Temps plein: Offre publiée hier: Date de fin : 24 septembre 2026 (Il reste 6 jour(s) pour postuler): R75591We anticipate the application window for this opening will close on - 24 Sep 2026Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type**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.Pour les diplômes de baccalauréat obtenus en dehors des États-Unis, un diplôme qui satisfait aux exigences de la réglementation 8 C.F.R. § 214.2 (h) (4) (iii) (A) est requis.**Exigences physiques du poste**Les déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.Les exigences physiques décrites dans la section Responsabilités de cette fiche de poste sont représentatives de celles auxquelles un employé doit satisfaire pour remplir correctement les fonctions essentielles du poste. Des ajustements raisonnables peuvent être apportés pour permettre aux personnes en situation de handicap de remplir ces fonctions essentielles. Rôles administratifs : dans l’exercice de ses fonctions, l’employé est régulièrement appelé à se déplacer de façon autonome. Il est également amené à utiliser un ordinateur et à communiquer avec ses pairs et ses collègues. Contactez votre responsable ou votre service RH local pour connaître les conditions de travail et les exigences physiques spécifiques à chaque rôle.**Autorisation de travail et parrainage** Chez Medtronic, nous nous engageons à favoriser un environnement dans lequel les employés peuvent s'épanouir et avoir un impact significatif. Conformément à notre approche de planification de la main-d'œuvre à l'échelle de l'entreprise, le parrainage d'autorisation de travail aux États-Unis (H-1B, TN, J, etc.) est proposé exclusivement pour les postes de niveau Principal et supérieur, où l'expertise spécialisée s'aligne sur les besoins métier à long terme. Les postes en dessous du niveau Principal exigent que les candidats possèdent une autorisation de travail américaine sans restriction au moment de l'embauche et pour la durée de l'emploi. Rejoignez-nous et aidez-nous à accomplir notre mission, à savoir soulager la douleur, rétablir la santé et prolonger la vie, en valorisant votre expérience et votre perspective uniques.**Alerte de fraude au recrutement** Nous avons pris connaissance de l’existence d’arnaques de type phishing visant les personnes à la recherche d’un emploi. Veuillez garder les points suivants à l’esprit : Postulez uniquement via les canaux officiels de Medtronic. Toutes les communications légitimes de recrutement de Medtronic proviennent de plateformes Medtronic approuvées et d’adresses e-mail officielles se terminant par @medtronic.com. Medtronic ne demande jamais de paiement ni d’informations personnelles sensibles (telles que des coordonnées bancaires ou des informations de sécurité sociale) au cours des premières étapes du processus de recrutement. Toute demande de ce type n’est pas légitime. Si vous recevez un message suspect prétendant provenir de Medtronic, n’y répondez pas, ne cliquez sur aucun lien et n’ouvrez aucune pièce jointe. Si vous avez des questions ou des préoccupations concernant l’authenticité d’une communication prétendument faite par ou au nom de Medtronic, veuillez nous contacter immédiatement à l’adresse [e-mail].**Avantages sociaux et rémunération****Medtronic offre un salaire compétitif et un ensemble d’avantages sociaux flexibles** Le cœur de nos valeurs est animé par un engagement envers nos employés. Nous saluons leurs contributions et partageons avec eux le succès qu’ils ont contribué à créer. Nous offrons un large éventail d’avantages, de ressources et de régimes de rémunération concurrentiels conçus pour vous soutenir à chaque étape de votre carrière et de votre vie personnelle.Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00This 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).