Quality System Specialist, South Africa needed at Medtronic

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 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:

• Bachelor’s degree in Engineering, Business Management, or similar.
• Min 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 9001 / ISO 13485).
• Excellent command of the English languages both verbal and written.