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选择求职条件高级供应商质量工程师，负责全球供应商质量变更管理及零部件鉴定策略，执行产品验收与测试方法验证，确保医疗器械符合相关标准。需每周至少4天现场办公。
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 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.
In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team. You will have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Perform, direct, or consult in supplier validations. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
Execute Product Acceptance Strategy and associated test method validation at suppliers.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and Supplier Owned Quality deployment for transferred products.
Must Have: Minimum Requirements:
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in a regulated industry OR PhD with 0 years relevant experience.
Nice to Have
Strong knowledge of Supplier Controls, including creation and maintenance of supplier files in the Approved Supplier List (ASL).
Experience with Windchill and Agile PLM systems.
Working knowledge of FDA regulations and ISO standards for implantable and non-implantable medical devices.
ASQ certification preferred, such as CQE, CQA, and/or CSQP.
First Time Quality Coach (FTQ) Six Sigma, DFSS, or Lean Green Belt/Black Belt certified
Knowledge of PPAP, part/product validation, and qualification processes.
Strong technical knowledge of metrology, measurement techniques, GD&T, measurement uncertainty, Gauge R&R, and statistical analysis using tools such as Minitab.
Demonstrated ability to influence and negotiate with suppliers and lead successful change initiatives.
Strong project leadership skills, including balancing risk and benefit, influencing cross-functional teams, and driving accountability for outcomes.
Excellent communication, organizational, presentation, judgment, and problem-solving skills, with the ability to operate strategically and tactically (especially root cause analysis).
In this role periodic travel is expected to suppliers or Medtronic facilities. Travel is less than 25%.
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 AskHR@medtronic.com.
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.
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).
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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