Careers That Change Lives
As a Configuration Assurance Administrator on the Quality Systems team, you will be a focal point for the processing and initiation of changes to documentation that is directly related to our products and to the Quality Management System vital to our medical devices which are sent out across the globe to benefit surgeons and their patients.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
Analyzes proposed changes of product design to determine effect on overall product and system. Coordinates modification records for management control. Establishes change orders and prepares for change authorization and documentation by company and subcontractor. Prepares reports of change effect on overall product. Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities. Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.
Responsibilities may include the following and other duties may be assigned.
- Maintain functional control of product Master Data, document change control and Quality System records.
- Analyze and coordinate proposed changes of product design and quality system processes to determine effect on overall product and system, coordinating with change owners, providing feedback.
- Prepare reports, including descriptive information and metrics, of change effect and impacts to their related products and processes.
- Review and analyze released engineering change data and coordinate changes with engineering, quality, support, manufacturing, and engineering data control activities.
- Ensure that customer requirements are implemented, and reviews change accounting activity to ensure compliance with configuration management policies.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s Degree with 2+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 0+ years of work experience in Quality and/or experience in a regulated industry
Nice to Have (Preferred Qualifications)
- Requires background in hands-on use of technical documentation including product design, manufacturing process, and quality systems.
- Requires knowledge of technical or operational practices within assigned discipline.
- Excellent communication skills- oral and written. Reading and writing accuracy is needed in establishing and maintaining order in handling records which may have complex numbering schemes and require clear and compliant descriptive language.
- 1+ years of configuration management or document control experience
- Ability to understand and provide detailed review and feedback related to new and revised technical documentation, applicable to product design, manufacturing processes and the Quality Management System
- Familiar with ISO 13485 quality systems
- Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat)
- Familiar with modern ERP systems, PLM systems and manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.)
- Office Skills: telephones, word processing, data entry, spreadsheet (PC), and database systems
- Strong interpersonal communication skills
- Able to work independently and within a team
- Energized and self-actuated
- Positive outlook
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
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