Quality System Specialist, Egypt

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.

Responsibilities may include the following and other duties may be assigned:

• 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.

Required Knowledge and Experience:

• Bachelors 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 masters degree in Engineering Business Management or a related field experience in the Medical Device or Pharmaceutical industries and strong communication and collaboration 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.

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 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