Job Description
About the Role
The Centurion: QA and Regulatory Officer is a critical role that requires a technical/mechanical engineering background to support long-term implantable medical devices, including machined and additively manufactured components. This position involves driving ownership and timely closure of CAPAs, nonconformances, and customer complaints, while maintaining and continuously improving the Quality Management System in compliance with ISO 13485 and MDSAP.
Key Responsibilities
- Drive ownership and timely closure of CAPAs, nonconformances, and customer complaints
- Provide technical QA oversight for machined and additively manufactured long-term implantable medical devices
- Draft, review, and approve manufacturing, process, packaging, sterilisation, and equipment validation protocols and reports (IQ/OQ/PQ)
- Coach and train staff at all levels on quality system, CAPA, and regulatory requirements
- Support and facilitate internal, supplier, and third-party audits
- Document control of all documents used in implementing and maintaining the quality management system
- Perform Quality review of documentation (Procedures and related forms and records)
- Facilitate the effective and appropriate close out of Nonconformances by liaising with departments to ensure actions and corrective actions are taken
Requirements
- Required minimum education: Tertiary (university) degree required
- Preferably in the engineering discipline or natural sciences
- Required minimum experience: 2 years
- Good communication skills – writing, presentation, and interpersonal communication
- High ethical standards
- Good understanding of statistics
- Computer literate: Microsoft Office Package
Qualifications
None mentioned.
Salary & Benefits
Salary: R 25 000 CTC pm.
How to Apply
Click the green “Go Apply” button below to apply directly online with the employer.
About Engineering Jobs in Tshwane
Tshwane, the administrative capital of South Africa, is home to a thriving engineering sector that encompasses various industries such as financial services, technology, and manufacturing. Generally, the job market for engineers in Tshwane tends to be competitive, with a high demand for skilled professionals. Typically, engineers in this region can expect to find stable employment opportunities, albeit with varying degrees of seniority and compensation.
When it comes to salary expectations, engineers in Tshwane can generally expect to earn between R800 000 and R1 500 000 per annum, depending on factors such as level of experience, company size, industry sector, and specific job requirements. However, it is essential to note that these figures are broad estimates and may vary significantly depending on individual circumstances.
Common skills required for engineering positions in Tshwane include proficiency in computer-aided design (CAD), programming languages such as Python or C++, and strong analytical and problem-solving skills. Typically, engineers in this region also possess a degree in a relevant field such as mechanical, electrical, or civil engineering, and may hold professional certifications like the Professional Engineer (PE) designation. Other commonly required skills include project management, communication, and teamwork.
Engineering roles are often found across various industry sectors, including financial services, technology, manufacturing, and infrastructure development. The technology industry, in particular, is a significant employer of engineers, with companies like Google and Microsoft often having a presence in Tshwane. Other common industries that employ engineers include the automotive sector, which is well-represented in the city due to its proximity to major manufacturers.
For those interested in pursuing a career in engineering, there are numerous opportunities for professional development and advancement. Typically, senior engineers can expect to take on leadership roles or transition into management positions, while others may opt for specialist fields like research and development or entrepreneurship. With ongoing industry developments and technological advancements, the field of engineering offers a dynamic and rewarding career path for those with the right skills and passion.
This information provides general career guidance. Actual salaries and requirements vary by employer.
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