Quality System Specialist, South Africa

at  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.
A Day in the Life
Join Medtronic as a Quality Systems Specialist and be a part of a company dedicated to enhancing people’s lives. Based in Johannesburg, South Africa, in this role you will be responsible for ensuring overall implementation of the Quality Management System and compliance in South Africa.
Medtronic is committed to revolutionizing healthcare to meet the diverse needs of people worldwide. Together, we accelerate the advancement of meaningful innovations, but our success hinges on assembling the right individuals for our team.

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.

Desirable would be Master’s degree in Engineering, Business Management, or similar.
Also experience in the Medical Device or Pharmaceutical industries would be beneficial
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 90,000+ 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.
Learn more about our business, mission, and our commitment to diversity
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• 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