Acumed Ltd.
As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.
Responsibilities
* Work with the Regulatory & QMS Manager to ensure that processes needed for the compliant operation of the Quality Management System are maintained
* Manage document control process, updating policies, procedures, work instructions and forms as required by the business.
* Administers the CAPA process in Activ (IL’s), ensuring timely closure of any actions required. Request updates from other stakeholders where IL’s have been assigned to them to avoid overdue actions.
* Manage internal IL’s from product quality complaints and service complaints for internal review and intercompany reporting purposes.
* Return any items which need investigating to LLC as per the IL in a timely manner.
* With the Regulatory & QMS Manager administer product recalls, working with the field teams and office-based teams to ensure a timely and accurate recall.
* Monitor on a weekly basis MHRA Field Safe Notices.
* Compile the information required for the Quality Management Review.
* Assist the Regulatory & QMS Manager in product registration in the markets the function is responsible for.
* Work with colleague at the manufacturing facilities in Addison and Hillsboro to implement relevant processes/ procedures to assist in harmonizing the UK QMS with that in the US.
* Ensure updated policies, procedures and work instructions are provided to the ComplianceWire learning management system per the training matrix.
* Check and respond to emails in a timely manner.
* Train staff when required.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
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