Senior Sustaining Design Quality Engineer (12 months FTC)

Job description

Job Advert Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living! In the role as Senior Sustaining Design Quality Engineer you will be responsible for ensuring that the safety, performance and quality of existing products for SNM conform to established standards are in compliance with all applicable global Quality System Regulations and critically maintain & monitor the risk/benefit profile of regulatory approved devices. What will you be doing?: Ensuring compliance of risk management files through the review of PMS/complaints data. Ensuring that risk management files and other associated quality documentation are complete and compliant by means of review and approval, as required. Support the timely review of risk management files in line with the complaints management process. Support the timely review of PMS data as part of monthly PMS trending. Ensure compliance to cGMP, cGDP, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures....