Job Information
Medtronic Senior CAPA/Quality Engineer - Neurovascular - Irvine, CA in Irvine, California
Careers That Change Lives
As a Senior Quality Engineer - CAPA, you will have responsibility for coordinating the Medtronic Neurovascular (NV) Quality CAPA portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don't recur. By supporting the Quality Function, you will provide critical compliance guidance and direction for CAPA impacting Complaints, Quality Systems, Standards, PHO and FCA. This position will be responsible for additional Quality Management System project work as needed.
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.
To learn more about Inclusion & Diversity at Medtronic Click Here
Location : Irvine, CA
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with Medtronic internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases.
Participate in CAPA Board activity and perform CAPA activities in Trackwise. Provide guidance, support, and mentorship to CAPA Owners regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
Collaborates with engineering and support functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing, and evaluating the effectiveness and accuracy of corrective actions ensuring no impact to products, processes or patient safety.
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with regulatory requirements.
May support CAPA 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.
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 or Science is required with a minimum of 4 years of CAPA/Quality experience
OR advance degree with a minimum of 2 years of CAPA/Qualityexperience
Nice to Have ( Preferred Qualifications )
Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.
Experience in medical device, pharmaceutical and/or a comparable regulated environment.
Experience working with non-conformances, corrective and preventive actions.
Strong analytical, process improvement, critical thinking, and decision-making skills.
Ability to educate people in the CAPA program.
CAPA documentation systems experience (e.g. Trackwise, PQM).
Influence management skills: ability to work constructively across all functions of the organization as well as external customers.
Project management skills.
Experience reviewing technical documentation.
Strong written and verbal communication skills.
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements.
Experience with internal and external audits.
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).
Min Salary
94400
Max Salary
141600
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.