Quality Administrator (FTC - Maternity Cover)
Quality Administrator - Fixed Term Contract (Maternity Cover)
Fixed Term Contract (Maternity cover)
Energist supplies high quality products to the medical and aesthetic treatment sectors via a worldwide network of distributors. Its products are largely electro-mechanical in nature and are assembled both in-house, at its Swansea manufacturing facility, and by specialist sub-contractors based in the locality.
As a registered medical device manufacturer, Energist maintains a Quality Management System in compliance with ISO 13485 & FDA CFR 21.
The role of Quality Administrator is to ensure product release and documentation for the QMS is maintained as part of document control and control of records. The position requires proficient communication and IT skills to support the Quality department on the day-to-day administration of key quality tasks such as batch release and documentation approvals.
Responsibilities:
* Ensure that general day-to-day activities such as batch release, review/approval of non-conformances, and deviations are completed within the expected timelines.
* Assist in the audits (pre-audit and post-audit follow up) to external (regulatory) requirements (e.g., ISO 13482:2016, FDA 21 CFR 820 & Medical Device Regulations).
* Responsible for reviewing and approving Quality Assurance Procedures (QAPs), Build Procedures (BPs), forms and other documentation in line with change process.
* Monitor supplier reviews and performance and update the QMS accordingly.
* Add, monitor and flag overdue nonconformances to the Quality Manager and department.
* Assist in metric data for the Quality department.
* Any other duties/projects as are reasonable and within the skills and ability of the post-holder.
* Ensure Health & Safety standards are upheld within the department and in general.
* Ensuring good housekeeping throughout the Quality Departmental areas.
Schedule:
* Monday to Friday
Ability to commute/relocate:
* Swansea SA6 8QY: reliably commute or plan to relocate before starting work (preferred)
Education:
* A-Level or equivalent (preferred)
Experience:
* Administration: 4 years (required)
* Document management systems: 1 year (required)
* ISO 13485: 1 year (preferred)
* United Kingdom (required)
Location:
Swansea, Wales, United Kingdom
Seniority level: Mid-Senior level
Employment type: Contract
Industries: Medical Equipment Manufacturing
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