Sr Quality Engineer

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 Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing environment, ensuring products and processes meet applicable quality, regulatory, and business requirements. This role is responsible for supporting investigations, nonconformance management, CAPA, change control, validation deliverables, risk assessments, process monitoring, and audit readiness. The position partners cross-functionally with manufacturing, engineering, supplier quality, and operations teams to resolve quality issues, drive continuous improvement, and maintain compliance with FDA, ISO, GMP, and internal quality system expectations. The ideal candidate brings strong technical problem-solving skills, quality systems knowledge, manufacturing process experience, and the ability to produce clear, technically sound, audit-ready documentation. 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 eet 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 Baccalaureate 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. Education: Bachelor’s degree in engineering required. Experience: Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or a master’s degree in engineering with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience. Preferred Qualifications Bachelor’s or master’s degree in Mechanical, Industrial, or Electrical Engineering preferred. Experience in medical device or other FDA/ISO-regulated manufacturing environments, including GMP expectations and inspection readiness. Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. Knowledge of validation concepts for equipment, processes, products, and software, including URS, SRS, IQ, OQ, PQ, risk-based validation, and implementation readiness. Experience supporting NPI, product transfers, supplier qualification, supplier performance monitoring, component qualification, and supplier quality improvement initiatives. Manufacturing process knowledge in areas such as machining, anodizing, final packaging, inspection, test methods, component qualification, or other process controls. Experience applying structured problem-solving and risk assessment tools, such as 5 Whys, Fishbone, FMEA, fault tree analysis, or similar methodologies. Experience using statistical and data analysis methods, including SPC, capability analysis, DOE, trending, sampling rationale, and process monitoring. Hands-on experience with tools such as Minitab, JMP, advanced Excel, Power BI, PowerPoint, SAP, JDE, Factory Works, or similar systems. Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement training/certification preferred. Experience using automation, dashboards, data extraction, 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected] . ‌ 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 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.