Job Information
Medtronic Sr Clinical Quality Specialist (Northridge, CA) in Northridge, California
Careers that Change Lives
We are excited to be hiring a Sr Clinical Quality Specialist to join the Medtronic Diabetes Operating Unit. In this role, you will be providing support to a Medtronic Diabetes clinical research study team. The Clinical Studies Support Coordinator III will independently perform diverse administrative and project duties.
This position will be HYBRID at Northridge Facility .
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Join our diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
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*A Day in the Life *
Responsibilities may include the following and other duties may be assigned.
The Sr Clinical Quality Specialist (CQS) supports multiple activities for the conduct of clinical research studies, Operations and special projects in compliance with applicable regulatory standards, policies, procedures and department requirements. The Sr Clinical Quality Specialist is responsible for coordination of Clinical Quality Operations activities to assure compliance with regulations and Medtronic standards, guidelines and policies. Coordinate activities involving regulatory activity such as field action management, product hold order management, regulation and policy analysis and implementation, compliance and management review. Basic understanding of Good Clinical Practices (GCP) desired (e.g., clinical trial management systems, inspection and audit compliance management and reporting systems). This position works with minimal supervision in consort with the department and study management.
Execute Clinical Operations Quality strategies
CAPA coordination, documentation, tracking, trending, analysis, reporting
QMS coordination, documentation, tracking, trending, analysis, reporting
Regulation and policy review, gap analysis, implementation, tracking
Execute Management review and reporting
quality metric development, collection, analysis, trending, and tracking
other management review function integration (e.g., supply chain)
Develop Quality processes to comply with applicable regulations, guidances and policies
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
Work with study teams to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Coordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Provide training on GCP and current regulations for those undertaking clinical studies
Attend and support clinical study meetings and Operations meetings (e.g., meeting facilitation, minutes, action item follow-up, arrangements, ad hoc assignments)
Support development/revision and implementation of procedures aligned with relevant global regulations and standards
Support for study teams during audit and inspection activity consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct
Determine obstacles, identify solutions, and implement plans in collaboration with management to meet study objectives, scope and schedules
Must Have: Minimum Requirements
Bachelor’s degree and 4 years of work experience in clinical/clinical research within healthcare industry (i.e., medical device, biotech, pharmaceutical)
Or, Master’s degree and 2 year of work experience in clinical / clinical research withinhealthcare industry (i.e. medical device, biotech, pharmaceutical)
Experience with Quality-related projects/tasks (i.e. audit, reviews, clinical quality operations)
Desired/ Preferred Qualifications:
Experience in medical device clinical trials/clinical trial setting
Familiarity of Operations and Quality processes
Experience in Project management and database systems (e.g., MS Project, Access, CTMS, SAP, Agile, Trackwise)
Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel)
Strong verbal and written communication skills, technical and problem solving skills
Able to read, analyze and interpret general business documents, technical procedures, and specifications
Able to write reports, business correspondence and procedure manuals effectively
Able to work effectively, independently and on cross-functional teams
Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
Develops solutions to a variety of problems of moderate scope and complexity
Willing to be flexible with work hours
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
EEO STATEMENT:
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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) on page 6 _ 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
96800
Max Salary
145200
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.