Sr Quality Engineer
Location Santa Ana, CA Careers That Change Lives
In this exciting role as a Sr Quality Engineer you will be a member of one of Medtronic's fastest growing therapies. You will have responsibility for ensuring world-class quality and reliability through the released product management (RPM) organization. The primary focus of this position is the quality and technical management of marketed products, monitoring, connecting with the field and responding to any signals from both established and newly launched products. Execution to business priorities and cross functional interactions are a critical element to this role, both with internal and external partners. Activities include enabling engineering support to significant product or process changes, iterations, failure investigations, CAPA processes, and resolution of quality issues in addition to facilitating change management improvement initiatives. This position will also provide support to the Product Development side of the business with a strong emphasis on design assurance for the design and development, transfer and commercial release of new products based on learnings gained from the released product experiences. Structural Heart and Aortic
The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves- aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta. A Day in the Life
- Represent QA in operation improvements/value stream projects and geography expansion projects.
- Prioritize timely completion of complaint investigations, Corrective Action and Preventive Action (CAPA) decisions, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
- Maintain, monitor and report trend analysis information on assigned products. Initiates discussions with management, Field Assurance, and Quality Assurance (QA) via the product quality meetings or other appropriate forum, when new failure mode trends are identified, providing field performance data as it becomes available.
- Represent QA in product Risk Analysis updates for assigned products. Maintain product risk management file for commercial product, including design and process failure mode effects analysis (dFMEA, pFMEA), post market surveillance report (PMSR), risk management plan and report (RMP, RMR).
- Support returned product analysis and failure investigation activities for manufactured products (explant lab).
- Function as a primary contact point between Field Assurance and QA as it relates to assigned products. Prepare response for regulatory inquiries (FDA, OUS regulators) as assigned.
- Conduct all engineering activities in compliance with FDA's Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other quality and regulatory requirements and standards.
- Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvement
Responsibilities may include the following and other duties may be assigned.
Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.
- 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 meet 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.
Bachelors Degree in Engineering, Science or technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or technical field with 2+ years of experience in Quality and/or Engineering. Nice to Have (Preferred Qualifications)
- Statistical techniques
- Program management
- Design control
- Medical devices
- Change management
- Root Cause Investigation methodologiesAbout Medtronic
Together, 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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)