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Associate Quality Systems Specialist
2 weeks ago
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeOur 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.Shift timings: 8.00 PM to 8.00 AM (Manila time)/ Hybrid work mode
As an Associate Quality Systems Specialist 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.
Responsibilities may include the following and other duties may be assigned.
Process change orders and prepares for change authorization and documentation.
Maintain functional control of product Master Data, document change control and Quality System records.
Review and analyze engineering change data and coordinate changes with various departments including engineering, quality, manufacturing, etc.
Analyze proposed changes of product design to determine effect on overall product and system.
Ensures that customer requirements are implemented, and reviews change accounting activity to ensure compliance with quality management policies.
Required Knowledge and Experience:
Bachelor's Degree within 1-2 years of experience in quality. Candidates from a regulated industry will be preferred
Quality management or document control experience
Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat)
Familiar with modern Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM) systems, and manufacturing documentation (i.e. Bill of Materials, item masters, Design History File, Device Master Record, etc.)
Excellent communication skills- oral and written.
Able to work independently and within a team
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.
Medtronic offers a competitive Salary and flexible Benefits Package
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.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here