RA & QMS Administrator - Part-Time

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.

Part-Time Office Based Andover, Hampshire.

RA & QMS Administrator works with the Regulatory & QMS Manager to assist with the planning and implementation of the Quality Management policy and procedures and ensure compliance with ISO13485 and applicable regulatory requirements. The role encompasses product and service complaints, CAPA’s, recalls, control of documents and internal audits so that they are processed/ completed in a timely manner.

• 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.