Quality Systems Specialist
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Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
We are seeking a driven and talented individual to join our Quality team. This individual will bring a passion for continuous improvement a strong communication skill set and an ability to have an attention to detail in combing through data and finding trends as they relate to the software applications we support.This position requires the ability to support the Medtronic IT systems validations maintenances strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk qualify their severity and address gaps in a methodical way to reduce overall organization exposure.
A day in the life:
- Provides oversight systems validations maintenances strategies and accurate review of specific documentation as required by the IT quality processes that ensure compliance with established standards and regulations
- Contributes to simplified validation approaches and coaching on how to leverage these approaches with their projects including resources like Business Analysts Developers Testers and Project Managers
- Collaborates with global IT quality peers and project teams on project scope schedule and compliance guidance
- Supports the external audit IT team on timely retrieval of quality documentation related to the systems reports and spreadsheet validation efforts they manage
Required knowledge:
- Bachelors degree
- Experience to work in a global virtual organization
- Solid understanding of the quality regulations and auditing techniques required for the medical device industry
- Ability to create and deliver presentations up to the Executive Committee level
- Strong influencing and negotiation skills
- High energy and motivation with an ability to quickly adapt to change
- Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs
NICE TO HAVE (Preferred Qualifications)
- Previous Medtronic experience
- Product non-product or healthcare software validation delivery experience
- Lean six sigma green / blackbelt or DMAIC skills
- CAPA root cause analysis methods skills
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.
Benefits & Compensation
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.
About Medtronic
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 95000 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
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
About Medtronic 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 excit ... View more
