SCT resources have a broad range of skills in different technologies. The large skill-set has been made possible by a conscious focus on strengthening our skills base. Every person selected for our team brings something new, something that adds to our offerings. We learn continuously, both on the job and through formal training programs.
Job DescriptionCompany: SystemCanada | www.systemcanada.com
World wide office: Canada - USA - Australia - UK - South Africa - New Zealand - Ireland - Japan
Job Description
Extensive experience in Product Development, Sustaining, Compliance to FDA regulations, Quality, Process and Manufacturing Engineering of medical equipment/devices
Responsible for the design and specification of tooling and equipment, validation & verification, design and development of processes.
Develop best practice in executing process development, scale-up, validation and manufacture troubleshooting.
Develop contractor site of manufacture and packaging supplier. Significantly improved the QA system and technical transfer procedure.
Provide cost improvement project and process optimization,
Prefer certified as Six Sigma Green Belt.
Prefer experience of CAPA investigation.
Experience on of Class I and II medical devices.
Experience on implementing structure following cGMPs for medical devices using ISO 13485.
Skills Required
- Extensive experience in product development, sustaining, quality, process and manufacturing engineering for medical devices
- Design and specification of tooling and equipment, and design and development of manufacturing processes
- Validation and verification of processes and products (process validation)
- Experience executing process development, scale-up, and manufacturing troubleshooting
- Develop and qualify contractor manufacturing sites and packaging suppliers; manage technical transfer
- Provide cost improvement projects and process optimization
- Experience with Class I and II medical devices
- Experience implementing cGMP structure for medical devices and working with ISO 13485
- Six Sigma Green Belt certification
- Experience conducting CAPA investigations
What We Do
System Canada Technologies is a leading technology solutions provider specializing in software development, IT consulting, and systems integration. Dedicated to delivering innovative and efficient services across various sectors, the company utilizes a customer-centric approach to tailor bespoke software applications to meet unique client needs. Their mission is to empower organizations through technology, enhancing operational efficiency and driving business growth through professional expertise.
