Quality Engineer

Overview

As a Quality Engineer at Cytiva you will drive quality adherence and risk management in a high-volume facility, partnering with the Quality Engineering Team to advance compliant manufacturing. You will lead investigations, CAPAs, and continuous improvement across production and QC processes, while supporting audits and new product transfer. You’ll work with cross-functional teams to translate data into actionable improvements that reduce non-conformances and enhance customer-aligned quality. This role offers impact in scaling robust quality systems within a global life-sciences context.

Responsibilities

• Facilitate compliance improvement within the Value Stream
• Report non-conformances and support investigations; drive closure
• Identify non-conformities in the production environment and pursue improvements
• Coordinate failure investigations and implement corrective/preventive actions (CAPA) and evaluate effectiveness
• Lead evaluation, trending and reporting of internal/external non-conformances to prioritize improvements
• Analyze rejects from production and QC tests to set improvement priorities and reduce external complaints
• Ensure production inspections and QC tests align with customer needs with QA Specialists
• Provide quality insights from data analyses and trending
• Validate and continuously improve production, QC processes and related standards
• Keep standards up-to-date; recommend internal OMS/procedure changes
• Support product development/transfer activities
• Review and develop departmental procedures
• Assist QA Manager during external audits at Pall Newquay
• Manage complaint investigations and identify improvement opportunities
• Lead CDTR projects to completion
• Support cost reduction programs and lead projects as appropriate
• Identify and implement improvement opportunities in daily management
• Apoyar procesos de gestión para facilitar las mejores prácticas

Key requirements

• Experience in ISO 9001 / ISO 13485 / pharma-regulated manufacturing environments
• Knowledge of systems used in regulated manufacturing facilities
• Background in Quality Assurance/Quality Control
• Experience with Danaher Business System tools and SPC
• Engineering degree with relevant experience; quality accreditation or certification advantageous
• Formal Lean or DBS training would be an asset
• PSP practitioner
• On-site role in Newquay

• problem solving
• team collaboration
• communication
• Quality Assurance/Control systems
• Non-conformance investigations
• CAPA management

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