BD - Johannesburg, Gauteng
Job Description SummaryQuality Management is responsible for strategic oversight and leadership direction within the Quality function. The Manager Quality for South Africa GTM is responsible for quality management, the quality system and quality & customer focused activities in primarily South Africa and secondarly the South African region under supervision of the Regional Director Quality – EMEA.
Manager Quality South Africa is reporting to Regional Director Quality EMEA and is member of the EMEA Quality team.Job Description
- Implement, manage and improve a quality system in accordance to BDX guidelines and standards, and compliant with local governmental regulations on a national scale which apply to BDX country activities, business needs and internationally marketed products and services. For South Africa this includes the support of the GTM licenses for BDX entities.
- Fulfils the role as BDX Quality Management Representative of the Quality system in the local country/market & subregion, ensuring that executive management is informed of Quality and customer issues or identified potential risks and that appropriate actions and resources are applied to quality and compliance concerns.
- Defines, implements and manages quality initiatives both internally and to customers and end users.
- Provide direction for internal processes improvement, including sales, after sales, technical services and other applicable business activities and needs and support processes and assist Business Management for implementation.
Duties / Accountibilities:
- Quality System
- Responsible for the following: Quality Assurance, internal auditing, CAPA, customer complaints management (in collaboration with the EMEA RCC), documentation control, quality control, suppliers evaluation and auditing
- Responsible for the maintenance, improvement and assessment of the effectiveness of the quality management system, in accordance with BDX standards and compliant with all applicable (inter)national regulations (ISO 13485 and South African laws & regulations).
- Plan, direct and control all quality activities supporting the introduction of new products, and the modification of existing products on the local markets. This activity does not include ownership of products (while owned by the Business Unit), but is supporting the in-country commercial organization from Quality perspective, as Quality business partner
- Maintain awareness of new and developing regulatory trends and requirements, to decide on follow-up for Quality management and QMS, in collaboration with Quality Compliance and Regulatory Affairs.
- Work with internal staff (country and business management), external suppliers and BDX employees to ensure quality processes meet regulatory and company guidelines.
- Act as primary contact for certification bodies.
- Measure and evaluate the effectiveness of Quality management system.
- Manage the relationship with internal and external logistics partners.
- Support in the coordination and local execution of field corrective actions (recall, hold, advisory notice) as per regional and Business Units and legal requirements, in cooperation with the Center of Excellence FSCA. Quality is coordinating the customer communication. Execution of this communication may vary per country and per BD entity.
- Provide training in BDX and regional (quality) policies and procedures to ensure the Quality Management System is understood and followed and quality awareness is promoted.
- Provide quality support to the sales and marketing team (e.g., for tenders & offers).
- Review the translation of quality deliverables as required.
- Manage Customer complaints reporting for the GTM organization, providing analysis, investigation, reports and feedback to executive managemen and customers, in conjunction with Quality Compliance (RCC and Vigilance teams), Regulatory Affairs, as required, from a customer, country and business perspective.
- Working with CGM and Business Leaders to provide metrics, dashboards and feedback to support and to improve CX.
- BDX Go To Market entities in South Africa
- Repair Centers in South Africa (multiple locations)
Primary Work LocationZAF Johannesburg - Woodlands DrAdditional LocationsWork Shift