Quality Engineer - #2189811

Role: Quality Engineer

Site Location: Cardiff

Rate: £40p/h via Umbrella

Hours per week: 37.5

Duration: 6 months

Purpose and Scope

The assignment will provide Quality Engineering support to medical device manufacturing operations, with a focus on maintaining effective manufacturing controls, resolving quality issues, supporting validation and change activity, and ensuring continued compliance with the Quality Management System and applicable regulatory requirements.

The successful candidate will be expected to work closely with Manufacturing, Engineering and Quality teams and be capable of operating independently within a regulated manufacturing environment.

Key Responsibilities

Depending on business priorities and individual experience, the Quality Engineer will support activities including:

• Nonconformance, deviation and CAPA investigation, including structured root cause analysis and implementation of corrective actions.
• Manufacturing quality issue resolution and ongoing shop-floor Quality Engineering support.
• Equipment and process qualification and validation, including engineering studies and IQ/OQ/PQ activities.
• Development, execution and review of validation protocols and reports.
• Change control, engineering change review and quality impact assessment.
• Risk management activities, including PFMEA, process risk assessments and control plans.
• Complaint and product quality investigations where manufacturing or process expertise is required.
• Review and approval of SOPs, work instructions, validation documentation, investigations, risk assessments and other controlled quality documentation.
• Manufacturing data analysis, process monitoring, quality trending and identification of improvement opportunities.
• New Product Introduction and manufacturing/process transfer activities.
• Internal, customer, notified body and regulatory audit support.
• Training and coaching of manufacturing and engineering personnel on applicable quality system requirements and quality engineering practices.

Expected Deliverables

Deliverables will depend on assigned work but may include:

• Completed nonconformance, deviation and CAPA investigations.
• Root cause analyses, corrective action plans and effectiveness verification.
• Engineering study, IQ, OQ, PQ and process validation protocols and reports.
• PFMEAs, risk assessments and control plans.
• Change control and quality impact assessments.
• Audit responses and remediation actions.
• Supplier quality investigations and corrective action documentation.
• SOPs, work instructions and other controlled QMS documentation.
• Manufacturing quality metrics and trend analyses.
• Training or quality guidance materials.

All documentation should be completed to an appropriate standard for review and approval within a regulated medical device QMS.

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