The roles of Senior Configuration Assurance (CA) Specialist is to provide expertise and leadership in the areas of configuration management, control, planning, and consulting.
The Senior Configuration Assurance Specialist is responsible for performing tasks that will drive the timely release and change of product documentation and supporting data throughout the products lifecycle.
This position will work with Engineering, Supply Chain, and other functional areas to ensure product data is processed in a timely fashion and in accordance with policies and procedures.
This position may be asked to communicate the status of documentation and its configuration to engineering and project management.
A Senior CA Specialist has a complete understanding and application of principles, concepts, practices, and standards and will be expected to, 1)analyze and develop solutions to a variety of complex problems, 2) participate in determining objectives and executing action plans to completion, 3) plan schedules and arranges own activities in accomplishing objectives, and 4) exerts some influence on the overall objectives and long-range goals of the department.
Senior CA performs tasks independently under general direction.
The Senior CA specialist role may be involved in the following activities:
Facilitate the timely change, approval, and release of product documentation and data to include ECR/ECOs, Design History Files, authorization released documents (deviations Product Holds, Product Release Authorizations), product/model numbers, JDE/SAP, manufacturing processes, and document archiving
Lead/assist in the creation, maintenance, and implementation of department processes, procedures, and work instructions as required to demonstrate compliance with the Quality System/
Monitor configuration management process effectiveness including the impact of changes and take the initiative to recommend configuration management process improvements.
Develop and manage relationships across multiple global organizations to address issues that affect the clients experience utilizing the PDM (Senior Management, Operations Management, Quality Leaders, Process Owners, MIT).
Be available to team members for consultation on issues arising from day to day operations
Partner with other functional areas internal and external to the department to facilitate process improvement
Provide training and consultation to clients on the use of the PDM tool and other department tools as required
Participate in and lead special projects as assigned
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:
REQUIRED YEARS OF EXPERIENCE:
4+ years of experience in a regulated environment including processing changes to design and manufacturing documentation.
2+ years of experience in Engineering Change Order for Documentation and Part Management
DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE:
Effective verbal and written communication
Demonstrated critical thinking skills
2+ years of experience with Quality Systems
Knowledgeable in MS Office such as Word, Excel, Power Point; Project Management;
Knowledgeable in Product Lifecycle Management Tools (Agile, Enovia preferred)
Knowledgeable in ERP Systems (SAP, JDEdwards preferred)
Knowledgeable in 6 sigma/DMAIC problem solving
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.
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 for extended periods of time, and communicate with peers and co-workers shich may require travel to and from multiple work locations.
Required to read small font on computer screen/monitor for 6-8 hours/day
Required to type and perform anlysis for 6-8 hr/day
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
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.uscis.gov/e-verify/employees
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.