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Sr Supplier Quality Engineer

Company: Medtronic
Location: Irvine
Posted on: May 3, 2021

Job Description:

Sr Supplier Quality Engineer Location: Mounds View, Minnesota, United States Requisition #: 210008FZ Post Date: Apr 07, 2021Careers that Change LivesIn this exciting role as a SeniorSupplier Quality Engineer, you willact as the point of contact within the Interventional Vascular and Structural Heart (IVSH) Manufacturing Network for all strategic issues relating to contract manufacturer (CM) and Original Equipment Manufacturer (OEM) supplier performance and improvement activities. While partnering with our CMs and OEMs, including sub-tier suppliers, as required, this position has accountability to support supplier selection, qualification and approval of new CMs/OEMs or changes to existing supplied products and processes, as well as oversight of performance and improvement activities. This position is responsible to maintain necessary controls and drive improvements relating to component / finished medical device quality in conjunction within our suppliers quality systems.A Day in the LifeResponsibilities may include the following and other duties may be assigned. + Lead in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associatedMedtronic policies and GMP/ISO requirements. + Work with CM/OEM suppliers to lead and drive systematic approaches to medical device quality issues. + Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality. + Drive supplier improvement/corrective action through the following activities: + Work with the IVSH CM/OEM supply base to drive corrective/preventative action based on feedback from incoming inspection, Medtronic/supplier internal quality metrics and customer complaints. + Lead work with production areas to implement quality-based improvements to current products and manufacturing processes. + Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented. + Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes). + Provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification. + Instrumental in the development and implementation of systems and processes for CM/OEM supplier management that are in compliance with corporate policies and industry standards/regulations and other quality requirements and guidelines. + Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the suppliers Quality Management System. + Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements. + Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification. + Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities. + As appropriate, institute appropriate root cause corrective actions relating to customer complaints andproduction defects and monitors for desired results.Must Have: Minimum Requirements+ Bachelors degree in Engineering, Science, or technical field with 4+ years Engineering and/or Quality experience, OR Advanced degree in Engineering, Science or technical field with 2+ years of experience in Engineering and/or QualityNice to Have (Preferred Qualifications)+ Quality System Lead Auditor experience (ISO 13485) + 5+ years experience in the medical industry or related field + Project Management experience + Supplier quality experience + 3-5 years experience supporting internal or external manufacturing processes across multiple areas, including, but not limited to: assembly, machining, molding (dip/injection), etc. + MS degree in science or engineering + Use and clear understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control) + Superb Oral and Written communication skills + Ability to work in a team/partnership environment + Computer Skills (Microsoft Word, Excel, Project, PowerPoint; Trackwise; Agile)About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.Physical Job RequirementsThe 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. (ADA-United States of America) Ability to travel up to 25% 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.

Keywords: Medtronic, Irvine , Sr Supplier Quality Engineer, Other , Irvine, California

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