Manufacturing Lead

**MANUFACTURING LEAD**

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**Introduction**

A Pretoria based med-tech company is seeking an experienced Manufacturing Lead with at least 5 years’ experience in a relevant field to become part of their growing team.

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**Minimum Requirements**:
**Education**:

- BCom Logistics / Business Management or related degree _(essential)_
- Certificate in Quality control / Manufacturing _(desirable)_

**Experience**:

- 5 years of experience in a relevant field
- Manufacturing experience in medical devices or technical industry
- Medical devices and or similarly regulated products
- Experience with quality management systems or regulated environments (ISO 13485 preferred, ISO 9001 acceptable, etc.)
- Supplier management
- Liaise with stakeholders

**Knowledge and Skills**:

- Knowledge of Shipping and buying procedures
- Advance Excel skills
- Project management
- Professional report writing
- Procedure writing
- Time management

**Key Performance Areas, Weights, and Objectives**

**Management**:

- Increase the team’s effectiveness with the following:

- Recruitment, selection, and orientation;
- Training and development;
- Assign accountabilities and plan;
- Monitor and appraise job and project results;
- Continuous improvement of systems and services
- Continuous improvement of individual team members.
- Develop a climate for offering information and opinions.
- Ensure conformity of products, servicing, and calibration centres to the quality management system in terms of the company’s Quality Objectives.
- Work to ensure team members and resources are applied in an efficient and effective manner to meet delivery requirements while achieving quality and safety standards.
- Ensure that team members follow defined manufacturing procedures and comply with quality requirements.
- Ensure equipment is within calibration date and all systems are functioning correctly.
- Ensure all records are completed appropriately.
- Ensure that the escalation procedure for quality concerns is followed.
- Manage work order closures and stock control transactions.
- Maintain visible lead for adherence to procedures and instructions.
- Undertake continuous training and development.
- Perform root cause analysis and resolve problems
- Identify business improvement opportunities within the organization.
- Identify and deploy the technical skill sets, resource levels, and systems to deliver projects, including the engagement of external resources as required.
- Conduct risk assessments of processes and tasks in the department.
- Responsible for daily management and support for the team to achieve operational success.
- Monitor time and attendance and ensure compliance with Company procedures.
- Monitor the completion of tasks and ensure good performance and record on appropriate systems.
- Consistently promote high standards through personal example and roll out through the team so that each team member understands the standards and behaviours expected of them.
- Communicate Key Performance Indicators (KPIs) from the annual strategic plan so that each employee is aware of expectations and deliverables
- Provide product expertise within the team and respond to operator queries.
- Work positively with support functions to fully define the processes/procedures/controls relevant to team activities.
- Provide support and input to continuous improvement activities within the team

**Manufacturing**:

- Manage manufacturing operations and oversee technicians responsible for device setup and calibration.
- Procure stock and manage inventory levels according to sales demand.
- Provide technical device support for sales and customer-related queries.
- Control and monitor audiometric measuring equipment, including scheduled maintenance and calibrations.
- Manage external manufacturing relationships, processes, timelines, and projects.
- Ensure a stable supply chain of all company’s standard hardware.
- Liaise with suppliers to ensure discontinued hardware is replaced by new hardware promptly and well in advance to ensure new hardware can be standardized by the company;s development team.
- Source new hardware and hardware suppliers as and when required

**Calibration**:

- Manage the calibration center partners to ensure all calibration hardware is calibrated annually.
- Ensure calibration partners perform all calibrations and device setups according to the company’s SOPs.
- Assist with the setup of new calibration centers as and when needed

**Record Keeping**:

- Compile relevant records as necessary for compliance with ISO, CE, FDA (and other) standards and requirements as applicable to assigned products.
- Efficient and effective reporting on strategies, prioritization, and tasks to the Line Manager.
- Efficient and effective reporting on the performance of products and systems.
- Take personal ownership of projects/products/systems and work quality as well as contribute to team development and the company’s ecosystem as a whole.