Quality Systems Specialist
Careers That Change Lives
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day In The Life
As a Quality System Specialist, you will have the responsibility of collaborating with cross functional teams to review, manage, and promote changes that meet the product requirements, company branding guidelines and global standards.
Responsibilities may include the following and other duties may be assigned.
- Process change orders and provide guidance in change order process in compliance with applicable procedures that support compliance with regulations and standards pertaining to medical device quality system change management.
- Work with change originators to maintain clear, concise and valid documents throughout.
- Process parts and documents changes in a timely manner according to requirements and procedures to support business requirements.
- Drive and facilitate in a timely manner the change, approval and release of documentation according to project schedules, including the resolution of resource issues relative to the processing of document change orders.
- Responsible for data entry integrity when transferring changes to product data in multiple systems.
- Responsible for ensuring that the best practices of Part/Document Change Management are followed.
- Monitor parts and documents changes management process effectiveness and contribute to problem solving/continual improvement discussions regarding change control process, including the impact of changes
- Participate in department meetings and performs other tasks and related duties as assigned.
Must Haves
- A Bachelor’s degree with minimum 2 years of experience.
Your Profile
- Proficient using the following software systems: Agile and SAP.
- Skilled in tasks associated with document handling, archiving and change management.
- Excellent analytical, verbal communication and writing skills.
- Ability to work in a team environment as well as independently
- Exhibits high degree of initiative and good judgment.
- Knowledge in using Agile PLM Import Tool and competent in Agile searches is preferred
- Knowledge of product design and assembly to make informed decisions about quality management so that the documentation is efficient and complete.
- Experience in the manufacture and development of product, preferably medical devices.
- Experience with and understanding of medical device quality systems.
- Strong attention to detail and accuracy.
- Ability to effectively contribute in multiple projects and priorities.
- Ability to interface professionally at all levels of the organization.
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.
