Iso Quality Auditor/coordinator

We have a really exciting role working for a leading manufacturer in their field, who are looking for a dynamic, personable and high energy quality coordinator who will be responsible for providing quality administration support to ensure delivery of highquality product to the customer.

You will focus on customer service, compliance, procedures and quality. You will have ownership of the development, implementation, and maintenance of the QMS processes to meet the requirements of applicable quality and regulatory standards (e.g ISO 9001:2015)

You will work in a really exciting team who has strong support from other offices in other area’s/countries so you always have great training and support.

**Compliance**
- Facilitate the migration of all documents from shared file directories into QMS SharePoint platform
- Provide active support, expertise, during audits and inspections, which includes practical experience supporting the cross-functional team.
- Facilitate and ensure the successful execution of certification and surveillance audits.
- Coordinate the SharePoint QMS Internal Audit Plans and configuration within the QMS w/ site audit teams
- Plan and execute efforts to drive regulatory audit recommendations/observations. Ensure that responses are clear, comprehensive, accurate, and well-written to mitigate potential for further regulatory actions.
- Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. Help track and trend data on common areas of vulnerability.
- Use the document management system to track progress of documents from inception through implementation
- Prioritize and expedite documentation release to ensure documents are issued in a timely manner
- Assists with managing SharePoint Document sites and site collections.
- Lead the internal audit team scheduling and activities, being the 2nd auditor on all audits and submit the post audit reports.

**Procedures**
- SharePoint QMS Maintenance of Quality System documentation (SOP's, procedures, forms, work instructions, drawings, etc.) Review for technical accuracy and update as required.
- Product Release
- Assist supply chain in the development continuous improvements of material certifications traceability to include tracking, repository retrieval, SysPro ERP system flags etcrequesting certifications from suppliers and related efficiency methods, internaldocumentation such as in-process records, in-house certifications
- Ad-Hoc QMS support as needed within the SharePoint QMS for Incidents records for product release are met such as Non-Conformance Reports (NCRs) aging dashboards and KPI management, workflow support. Can include Incident and CAPA’s related to internal/externalaudits, customer complaints
- Actively work within the CAPA system, provide inputs to the CAPA Review Board Supplier Corrective Actions SCAR’s) and Monthly Data Analysis
- Coordinates supplier rejects using the RTV system ensuring suppliers complete root-cause investigations related to product and components rejections in a timely manner.
- Work with the SP Ipswich and wider SP team to resolve issues that involve quality system gaps, production non-conformances or situations that involve component qualification or procurement.
- Facilitate follow-up and action with cross functional team to resolve Customer Out of Box Failures (OBF’s) Quality Alerts with timely feedback based on data, convened and coordinated 8Ds and root cause analysis meetings. Using Quality tools to implementationof Corrective and Preventive actions. (CAPA)

**Experience**
- We are looking for someone with some exposure to ISO who has experience within a similar role, in a similar industry. Training can be given.