Senior Supplier Quality Engineer

Medtronic•Toledo, OH

2d•$99,200 - $148,800•Onsite

About The Position

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.

Requirements

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.
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.
U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

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.

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.