Process Engineer Development Improvement
System Canada Technologies · Boston, MA, us ·
- Employment
- Contract
- Category
- Industrial engineering
Company: 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.