Quality System Specialist
Medtronic
Posted 30+ days ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
- Act as a first point of contact on Quality for the local distribution / sales office leadership team and employees; representing the local voice of the customer to the Global Quality teams
- Build knowledge of local process owners, support detailed process implementation, and use of Quality tools while establishing and documenting local processes to meet local regulations
- Manage ISO (International Organization for Standardization) certification activities for applicable standards of ISO 13485:2016, and provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Prepare Quality update meetings to review and discuss with local distribution / sales office Quality Performance (Key Performance Indicators) and ensure follow up and audit readiness preparation
- Provide Quality support to Logistics outsourced process suppliers (Medtronic requirement sharing, conducting Management Reviews and Quality Walks, managing Supplier Corrective Preventive Actions, Change Control etc.), and ensuring the Quality management of local suppliers, distributors, and original equipment manufacturers
- Support business model changes (go-direct initiatives, new activities assessment, local labelling, etc.)
- Increase awareness on Quality topics and embed a Quality mindset in the organization to put patients first and support local organizations on identifying improvement areas.
Desired Candidate Profile
Required Knowledge and Experience:
- Bachelor s degree in Engineering, Business Management, or similar
- Minimum 2 years of relevant work experience in a highly regulated environment (for example: Pharmaceutical, Medical Technology, Automotive or in a Logistical operational environment)
- Knowledge and experience with ISO standards (ISO 13485 / ISO 9001)
- Excellent command of the English languages both verbal and written.
Preferred qualifications include a master s degree in Engineering, Business Management, or a related field, experience in the Medical Device or Pharmaceutical industries, and strong communication and collaboration skills.
Company Industry
- Medical
- Healthcare
- Diagnostics
- Medical Devices
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Quality System Specialist
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Medtronic
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. Join Medtronic as a Quality Systems Specialist in Cairo, Egypt, and play a key role in ensuring the effective implementation of our Quality Management System and compliance standards. At Medtronic, we are committed to transforming healthcare and improving lives through meaningful innovations. Our mission of engineering the extraordinary depends on passionate and skilled people like you. This is your opportunity to join a global leader, make a real impact, and help us shape the future of healthcare. 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.
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