Quality System Specialist, Egypt at Medtronic

Cairo, Cairo, Egypt

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering, Business Management, or similar
Minimum 2 years of relevant work experience in a highly regulated environment (e.g., Pharmaceutical, Medical Technology, Automotive, or Logistical operational environment)
Knowledge and experience with ISO standards (ISO 13485 / ISO 9001)
Excellent command of English language both verbal and written

Responsibilities

Act as 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 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

Skills

ISO 13485

Quality Management System

Regulatory Compliance

CAPA

Change Control

Supplier Management

Audit Preparation

KPI

Process Implementation

Management Reviews

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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