Job Information
Medtronic Senior Quality Engineer in Irvine, California
Careers that Change Lives
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. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. See our videos below to learn more about our diverse workforce why Medtronic is an employer of choice.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
In this exciting role as a Senior Quality Engineer, you will provide leadership and direction for the day-to-day functions of the respective Access, Intraluminal, or Intrasaccular Franchise Product Lines. You will have responsibility to support implementation of projects and activities to define, design, develop and deliver new processes, quality improvement, and change initiatives. This role will support Manufacturing Operations, Process Engineering, and Operational Excellence requests for quality support at the Medtronic Toledo site in Irvine, CA
To drive the synergies across the 4 sites that exist in Orange County under Vascular Therapies Implants and Drug and Chemistry Technologies, we are introducing the OC Campus Strategy, which will include the harmonization of all Orange County manufacturing campuses including:
• Santa Ana – Surgical Valve and Transcatheter Valve
• Anaheim (Vascular Medcure) – Capere Thrombectomy and Embolectomy system
• Irvine – Stroke/Aneurysm and Embolization
• San Juan Capistrano (Avenu) – Ellipsis Vascular Access System and Power Controller
The vision of the OC Campus is to accomplish harmonized standards and process amongst the sites.
Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business. Medtronic seeks candidates who will meet our customer expectations by striving without reserve for the highest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. To learn more, we invite you to visit Medtronic Benefits (https://benefits.medtronic.com/)
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
To learn more about Inclusion & Diversity at Medtronic Click Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Develop, execute, and analyze Test Method Validations to support pre-commercial product lines for both variable and attribute features in scope of inspections.
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Prepares reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
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.
Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.
Interface with Production, Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
Identify, analyze, and manage risk through product life cycle with use of FMECA and other risk management tools.
Provide training, leadership, and guidance for junior quality engineers and/or technicians.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors’ degree in Engineering, Science or Technical field.
Minimum of 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
Nice to Have
ASQ Quality Engineer Certification.
Previous Medtronic and/or Medical Device experience is helpful.
DMAIC Lean / Six Sigma Certification.
Manufacturing Management experience within a controlled and regulated industry.
Ability to communicate effectively and diplomatically with a wide variety of people.
Good writing and documentation skills.
Good organizational and verbal communication skills.
About 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)
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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Min Salary
90000
Max Salary
135000
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.