Job Description

Who we are:

Established in 1993, Tristel is a global infection prevention business, headquartered in Cambridgeshire, UK. We have subsidiaries in the Netherlands, Belgium, France, Germany, Switzerland, Spain, Italy, China, Hong Kong, Malaysia, Australia, New Zealand, and the United States.

The objective of Product Surveillance is to monitor, manage, and maintain medical device lifecycles, ensuring performance, quality, and safety of Tristel-manufactured products, globally.

Responsibilities:

Carry out market research, including research of similar devices and technologies in the market, and engage with distributors, importers, and users to gain product feedback. Periodically coordinate post-market surveillance (PMS) projects, in accordance with procedures, overseeing the collection of PMS inputs within a report, with analysis and trending of data, establishing any necessary outputs. Identify and scope opportunities for design improvements, based on feedback and/or PMS findings, creating project brief proposals for the Design team to execute, if deemed appropriate. Create, maintain, and follow standard operating procedures (SOPs), work instructions (WIs), and templates, based upon regulatory, health and safety, and International Organization for Standardization (ISO) requirements, to improve product performance, safety, and quality. Ensure product design, risk assessment, and technical files are maintained within the Quality Management System (QMS), alongside other departments. Ensure product regulatory compliance with national and international standards and legislation, by updating product materials (labelling, user guides, carton artwork). Engage with external suppliers to ensure accurate manufacturing of componentry and end-products, and engage with external service and installation engineers to ensure performance, safety, and quality of product. Support the management of minor design projects in accordance with approved procedures. Own and resolve product non-conformities, undertaking necessary corrective actions.

Requirements:

Communication (the ability to establish a connection with people at every level and both understand and be understood). Organisation (the ability to work on multiple tasks at once and keep clear and accurate records, in good order). Humility (the ability to listen, admit mistakes, have empathy). Process and data driven, with an analytical mindset. Strong Microsoft Excel skills, or willingness to learn.

Qualifications:

Education up to A-levels or equivalent as a minimum. No specific qualifications required. An interest or background in quality assurance and/or regulatory affairs is desirable, but not a requirement.
Job Types: Full-time, Permanent

Pay: 25,000.00-32,000.00 per year

Benefits:

Additional leave Company events Company pension Cycle to work scheme Discounted or free food Enhanced maternity leave Enhanced paternity leave Free flu jabs Free parking Life insurance On-site parking Private medical insurance Sick pay
Schedule:

Day shift Monday to Friday No weekends
Application question(s):

Do you require sponsorship for this role?
Work Location: In person

Reference ID: PMS