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Job Description
- Req#: 152483
- Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Author and/or review and approval process, product, and software validations
- Drive Quality KPI’s to acceptable levels.
- Support and process Non-Conforming Material Reports (NCMRs), CAPAs and Audit Findings
- Provide support during audits and serve as an SME on areas of expertise.
- Work with various Design Team in support of a significant new product launch
- Provide Quality Engineering support to the Incoming Inspection Team.
- 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.
- Bachelor’s degree in Engineering, Science or related technical field and a minimum of 4 years of relevant quality engineering experience OR an advanced degree in Engineering, Science or related technical field with a minimum of 2 years relevant quality engineering experience
- Experience working in Medical Device or other regulated Industries.
- Experience and working knowledge of FDA regulations/ISO standards for medical devices.
- ASQ certification in Quality Engineering
- Validation experience, especially with software.
- Proven leadership for process and system improvement
- Strong interpersonal, organizational and project management skills
- Demonstrated skills in decision making.
- Demonstrated ability in coaching/developing team members.
- Experience as a Subject Matter Expert with NCMRs and/or CAPAS
- Posting Date: Feb 22, 2024
- Travel: Yes, <>
- Salary Min: 90,000
- Salary Max: 135,000
Careers that Change LivesLOCATION: This role is expected to sit onsite in Louisville, Colorado.In this exciting role as a Senior Quality Engineer, you will be responsible for supporting Manufacturing operations at the Louisville, CO site. You will gain experience with products across Medtronic’s Cranial & Spinal Technologies (CST) portfolio that supports your development and growth. The Sr. Quality Engineer reports to the site Operations QA Manager and focuses on providing Quality support as well as risk assessment for critical operations across the Louisville site.
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.
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
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.
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
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
As the Sr. Quality Engineer, you will
Must Have: Minimum Requirements
Nice to Have
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 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)
A commitment to our employees lives is 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 .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply to others).
Additional InformationAbout the company
Medtronic plc is an American-Irish registered medical device company that primarily operates in the United States.