** Driver’s licence and own vehicle essential – not negotiable **
** The position is available immediately. **
** Demonstrated knowledge of relevant International standards particularly ISO 13485 or ISO 9001 essential. **
** 2 years’ experience in QMS administration role. **
Our client offers world leading integrated solutions for the care of people with reduced mobility and related conditions. Based on extensive knowledge and advanced technology they provide superior medical equipment for safe patient handling and hygiene, medical beds and Therapeutic Support Systems™, wound healing, DVT prevention, disinfection and diagnostics. The result is improved care efficiency and a safer environment for both patient and career.
CV must include summary of employment history and reasons for leaving/availability, Race, Gender, residential address, indication of reliable/own transport. Understanding of support structures as ad-hoc after hours work will be required. Clear copies of ID, driver’s license, matric certificate, tertiary qualifications certificates, latest payslip including company contributions and bonuses received.
The purpose of this position is to provide support to the overall Africa Team on QRC aspects. The QRC Assistant will assist in the implementation of Quality Assurance, Regulatory Affairs and Post Market Vigilance for the client.
This role works in collaboration with the local SSU Team to define and implement QA strategies, promote quality in service delivery, continuous improvement, monitoring compliance, identifying and evaluating deficiencies, and minimizing business risk while operating within the ISO 9001 and 13485 Quality Management Systems and client SOP-124 Sales and Service Unit QMS.
The incumbent will support the QRC Manager in ensuring products supplied in Africa meet and are in compliance with the requirements of regulatory bodies and local law.
A full assessment will be part of the search and hiring process.
- Product Registration with local Regulatory Bodies and any local authorities as required by local and international law.
- Assist in obtaining ISO 13485 certification for local Quality System as required by South African Health legislation.
- Support in implementation, maintenance and certification of ISO 13485:2016 at all sites.
- Assist in integration of Sales and Service Unit QMS and ensure on-going compliance.
- Assist in efficiently managing non-conformances and CAPA within the business.
- Maintenance of document and data control.
- Maintenance of internal audit schedules as well as participate in audits conduct by Group or Regional QRC department.
- Assist with internal quality audit
Assist the QRC Manager with Regulatory Compliance for the African SSU
Assist the QRC Manager with Post Market Activities - TrackWise (Company platform for Quality reporting):
- Ensure warranties, unplanned service, product incidents, BNPC, non-conformances and CAPA are reported into Trackwise as instructed or required by Local or Global SOP.
- Ensure input meets expectations.
In conjunction with the QRC Manager, assist with the following:
- Be an agent for good QRC practices.
- Build team’s knowledge of QRC requirements.
- Induct new employees on QRC requirements.
- To identify, lead and direct process improvement of QRC activities.
- Assist with ensuring that business continuity plan is implemented and audited.
- Assist with audit site processes and procedures for compliance.
- Audit external suppliers for compliance to QMS practices.
- Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes.
- Assist with design and implementation of improvements in communication, monitoring, or enforcement of compliance standards.
- Keep QRC Manager informed of all quality, regulatory and vigilance issues that will have an effect on the business.
- Ensure that Quarantine “Store” is neat and that faulty devices are accounted for.
Any projects or tasks as specified or requested by the QRC Manager, Senior Director, Quality & Regulatory Compliance, Sales and Service – RoW.
Qualification (Knowledge, Skills and Abilities)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Each organization shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
- Demonstrated knowledge of relevant International standards particularly ISO 13485 or ISO 9001 essential.
- Knowledge of current risk management standards, principles and frameworks.
- QMS and/or Regulatory Affairs implementation in the Medical Device or related industry
- Knowledge of legislation and the ability to acquire knowledge of the relevant Codes of Practice.
- 2 years’ experience in QMS administration role.
- Experience with handling customer complaints.
- Participated in creation and implementation of a certified QMS (ISO 13485/9001).
- Experience with ISO13485 will be a distinct advantage for this role.
- Experience in monitoring, reviewing and completing activities according to previously defined priorities.
- Demonstrated expertise with Microsoft Windows operating system and MS Office applications.
- Takes initiative, positive attitude and willingness to assist.
- Practical and logical understanding.
- Team player and work independently.
- Excellent interpersonal and communication skills.
- Strong impact and presence.
- Ability to motivate and influence people.
- Strong organizational skills.
- Ability to manage several projects.
- Confident in engaging and working with senior management, project manager and contractors.