Commercial Quality Specialist

3 weeks ago

Johannesburg, South Africa Abbott Laboratories Full time

**Job Title**

**Commercial Quality Specialist**

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

**Working at Abbott**

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

**The Opportunity**

This position works out of our Johannesburg location in the Abbott Rapid Diagnostics Division. In this division we’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

This position will ensure that product(s) and/or service(s) meet the established standards of quality including reliability, usability, and performance from a Distribution business standpoint. Works closely with all staff members and promotes Abbott’s Quality Requirements. Contribute and support towards the Quality Management system and aid in maintaining its effectiveness and efficiency for the Africa & Middle East region, and when required for EEMEA region. Works towards ensuring Abbott Global Procedures are integrated into the local quality management system and ensure its implementation. Perform & manage distributor assessment(s) and audit(s) as required. When required support the organization with conducting & managing supplier assessment(s) and audit(s).

**What You’ll Do**
- Ensures the processes needed for the Quality Management System (QMS) are established, implemented and maintained.
- Maintain the Quality System to ensure it meets the local quality management system and Abbott Quality System requirements.
- Supports departments in finding solutions to issues raised and escalate to the Quality Manager for support when required.
- Assists with the set up and coordinate Quality meetings including Management Reviews, the distribution of minutes and follow through of actions for verification and closure.
- Prepare the minutes of the MR meetings for review with the team and Quality Manager.
- Supports the review of the Quality Tracker on a monthly basis and advise outstanding items for closure to departments.
- Ensure that all Quality Communication such as Product Hold are executed and all relevant documentation completed, approved, submitted, and filed to ensure no further distribution of product.
- Identifies any risks noted and capture in the Risk Register and escalates to the Quality Manager
- Ensures the Audit programs devised are adhered to and all audits are performed in accordance with said procedures.
- Provide advice on disposition for Product Deviations receipted at selected Abbott 3rd party warehouse and logistics company.
- Approve all destruction requests for nonconforming products.
- Authorize product returns at selected 3rd party warehouse and logistics company, advise on disposition after inspection and investigation of product handling during storage and transportation.
- Assist in ensuring that all the required Quality Assurance related training is performed, and records filed/retained.
- Perform distributor/supplier Audits/ Pre-assessments for potential distributors identified by commercial within the EEMEA region in support of the distributor on-boarding process.
- Perform distributor Audits/Assessment for already existing distributors in EEMEA region as required.
- Report and track any potential Abbott product theft, diversion, counterfeit, and parallel importing for Africa and Middle East, and when required for EEMEA region.
- Uphold the company’s core values.
- Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
- Responsible for management and satisfactory resolution of Quality Incidents (non-conformances) in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
- Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of

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