Overview
As Quality Engineering Manager, you lead a Quality SME and a technicians/engineers team to support manufacturing and customer complaint investigations. You author and review technical reports, offering coaching to develop the team. You collaborate cross-functionally to deliver compliant projects and implement new procedures. You monitor KPIs and drive continuous quality improvements. This role combines leadership, regulatory expertise, and hands-on quality engineering to advance Cytiva’s mission of accelerating life-changing therapeutics.
Responsibilities
- Act as Quality SME and manage daily deployment and priorities of the Quality Technician/Engineering team to support investigations and improvement actions
- Author and review technical reports, providing feedback and coaching on best practice
- Provide skills and career path development and guidance to team members
- Work cross-functionally with operations, engineering, supply chain and maintenance to deliver projects and compliant outcomes
- Deploy and embed new procedures and policies ensuring compliance to requirements
- Maintenance, reporting and escalation of departmental and site KPIs
- Support other functions within the department as necessary
Key requirements
- Degree or equivalent in Scientific, Engineering or Quality discipline (or equivalent working experience)
- At least 5 years experience managing teams in a manufacturing-based quality environment
- At least 5 years experience in a relevant Quality Engineering role (pharma, med device, automotive, aerospace) with compliance in fast-paced business
- Advanced level of operating within an ISO9001 environment; knowledge of ISO13485, 21CFR820, GxP and Pharma regulations advantageous
- Experience of writing problem statements and executing CAPA best practice
- Demonstrative experience using ISO14971 risk management principles and application
- Experience deploying strategy and delivering objectives within a team
- Cross-functional collaboration
- Coaching and people development
- Strong communication
- ISO9001
- ISO13485
- 21 CFR 820
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