Current jobs related to Biomedical Engineers - Cirencester - Corin Group

Vigilance Coordinator required to work within our Global Vigilance team, based at our Global HQ in Cirencester, Gloucestershire 2-3 days a week on a hybrid full-time contract.

Do you have a mechanical or biomedical engineering degree, a great eye for detail, and a willingness to work within a global orthopedic medical device organization?

Corin is looking for a Vigilance Coordinator to join our high-performing team, working in a fast-paced, agile environment. You will be responsible for ensuring that all Regulatory and Quality Assurance requirements are routinely met with regards to the timely review, investigation, and reporting of product-related issues, the monitoring of trending information from a variety of sources, to pre-empt potential issues.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. We offer a unique combination of clinically proven hip & knee solutions and world-leading technologies. Our Apollo & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, more consistent results, and improved recovery rates.

The key responsibilities of the Vigilance Coordinator are to:

• The day-to-day administration of all aspects of Complaints/Vigilance, including product complaints, on a site level at Corin UK and to always maintain compliance with the Quality Management System (QMS).
• First point of contact for complaints and feedback received from Corin.
• In charge of making initial case triage assessment of complaints and assessing initial risk and severity.
• Evaluate that the information received is sufficiently detailed and request and obtain additional details where incomplete.
• Prepare the assessment of the complaints reporting to the health authorities and the notified body within the appropriate timelines and report cases as applicable.
• Transfer data into the appropriate e-QMS “Vigilance System” (as required).
• Coordinate Root Cause Investigation activities on a site level (as required).
• Support customer response activities in collaboration with Vigilance Manager or Team Leader.
• Process and close the Complaints files.
• Provide weekly reports to the Manager/Team Leader.
• Assist with returned item investigations.
• Maintain hard and soft copy case files.
• Process feedback and follow-up activities.
• Provide ad-hoc admin support to the team.
• Support continuous process improvement.

The ideal Vigilance Co-ordinator will have the following skills and competencies:

• A Bachelor’s degree, master's, or PhD in Biomedical Engineering, Life Science, or a bachelor’s degree and related experience.
• Excellent verbal and written communication skills in English
• Basic understanding of technology or science
• Good knowledge of Office Tools (Word, Excel, Internet, PowerPoint) & ERP (SAGE / eQMS).
• An understanding of adverse event reporting and be proficient with MS Word and Excel.
• Knowledge of the Medical Devices Directives (MDD) and future Medical Device Regulation as applicable to role is desired
• High standard of attention to detail.
• Good verbal and written communication skills.
• Ability to work on own initiative.
• Team player.
• Good time management skills, ability to multi-task and deliver activities to timelines
• Professional approach to work.