Share this job with your friends, family and co-workers...
THIS JOB ADVERT IS STILL ACTIVE...
QUALITY ENGINEER - 362008
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
Our client in the Medical Technology field is seeking to employ a dynamic Quality Engineer.
Duties & Responsibilities
To assist with maintaining a company-wide quality management system (QMS), medical device certification and product development. This includes documentation of specifications and procedures, research, and development, prototyping and keeping up to date with the latest local and international standards. Increase company profitability by driving product success by designing efficient and scalable systems/products and ensuring on-time and on-budget delivery thereof. Takes ownership of assigned products and keeps a handle on product and project aspects including business models, specifications, budgets and financial models, progress tracking, management of resources and team capacity.
Minimum education (essential):
Diploma in Industrial Engineering, Quality Managements OR Relevant Quality Management Certification
Minimum education (desirable):
BEng (Industrial or similar).
Minimum applicable experience (years):
Required nature of experience:
Quality Management Systems (ISO 13485, ISO 9001, or similar) and regulated environments Internal audit experience
Risk Management (ISO 14971)
Medical Device Software Life Cycle (EN 62304)
Business Analysis within the IT, software, or medical device field
Development of project, product, and system specifications
Requirement gathering and documentation
Skills and Knowledge (essential):
Excellent computer proficiency (especially in MS Office Excel)
Report and proposal writing skills
Business process design
Quality Management Systems (ISO 13485, ISO 9001, or similar)
Key Performance Areas, Weights & Objectives:
Define quality procedures in conjunction with operating staff.
Set up and maintain controls and documentation procedures.
Conduct internal audits on existing processes.
Conduct supplier management in line with QMS processes.
Support in keeping medical device risk files and device literature valuation are up to date.
Conduct training on the QMS system and associated processes.
Assist with compliance of medical devices to relevant medical device regulations.
Conduct post market surveillance activities in line with QMS processes.
Research new regulatory requirements and compliance related topics.
Compile and disseminate information to relevant employees, training them as necessary on regulatory requirements.
Communicate with notified bodies regarding quotes, schedules, documentation, and audits.
Support software development requirements for medical device software.
Full cycle Project and Product Management including capacity management, stakeholder engagement and resource tracking.
Multi-task on a suite of projects and products, all within different stages of development and implementation.
Compile intuitive system and product requirements and specification design, in terms of researching, consulting and analysing needs.
Follow best practice design and development methodologies in sustaining high quality, clean, auditable, and manageable products, and systems.
Compile relevant specifications documents, UX, UI designs, wireframes, and test cases.
Effective system testing and approval, including the management of release notes and effective communication with stakeholders on changes and/or improvements.
Work with front-end, back-end and mobile developers, marketing, sales, research, and design departments to ensure a holistic management process of project management.
Ensure conformity of products to product requirements in terms of the Quality Objectives which includes regulatory and legislative compliance.
Identify technology limitations and deficiencies in applications and associated processes, procedures, and methods within the department.
Continuous improvement of existing products, systems, and processes within the department.
Identify issues, bugs, and bottlenecks and devise solutions to these problems within the department.
Business Processes and Strategy:
Business process improvements, operationalization, and optimization.
Develop strategies for the implementation of products, projects, or systems, including commercialisation, legal and operational aspects.
Risk analysis and mitigation.
Manage tasks and priorities within product suite or assigned department.
Increase profitability of products through the streamlining of development, manufacturing, and maintenance thereof.
Efficient and effective reporting on strategies, prioritisation, and tasks to Line Manager.
Efficient and effective reporting on performance of products and systems.
Take personal ownership for projects/products/systems and work quality as well as contributing to team development and the ecosystem as a whole
Compile relevant records as is necessary for compliance to ISO, CE, FDA (and other) standards and requirements as is applicable to assigned products.
Accomplish objectives by establishing plans, budgets, and results; reviewing progress and making mid-course corrections to ensure optimal outcomes.
Maintain documentation and SOPs within the department.
Package & Remuneration