Up to £0.00 per annum
4 months ago
The role works mostly post-market, sustaining engineering to support products that have been released to the field. You will be responsible for conducting product performance investigations that will lead to design, manufacturing and use improvements.
Responsibilities include but not limited to;
*Participate in the complaint handling process by leading complaint investigations.
*Apply engineering judgement and product knowledge to properly assess returned devices.
*Perform complaint investigations, including, as appropriate, decontaminate and analyze returned devices, determine root cause, identify non-conformances, initiate health risk assessments, and generate reports and trends
*Proactively work with other departments (R&D, Manufacturing, Quality, Design Assurance, Marketing, Regulatory, Field Service) to review returned devices and root causes, as necessary, to support investigations.
*Meet goals and metrics to timely and accurately complete investigations of complaints in support of medical device regulatory reporting.
*Identify high-level complaints or incidents that may have a significant impact on the business.
*Proactively follow steps to judge escalation of high priority and/or complex product complaint investigations and corrective actions.
*Perform or arrange for testing on complaint products, as necessary.
*Support investigation into complaints of distributed devices and supplier-manufactured products/components, working with external contacts and Supplier Quality to facilitate their investigations.
*Identify and implement changes to relevant QA monitoring programs to improve effectiveness and efficiency.
*Perform data analysis to generate product performance trending reports for senior leadership review and decision-making.
*Produce and maintain documentation in accordance with applicable regulations.
*Participate in external audits and inspections as a subject matter expert on complaint investigations and returned product analysis
Education and Role Requirements
*Bachelor's Degree in technical or life sciences, or engineering.
*Complaint handling experience in a regulated environment
*2-5 years Quality Engineer experience.
*Experience with electromechanical equipment or injection molding products is a plus.
*Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO
*ASQ Quality Engineer and/or Six Sigma Green Belt certification a plus.
In accordance with the Equality Act 2010, if you require an alternative form of application please click the following link: Flexible Application Process - https://www.theecsgroup.co.uk/work/flexible-application-process