Responsibilities
- Act as Quality SME and manage daily deployment and priorities of the Quality Technician/Engineering team to support customer and manufacturing complaint investigations and improvement actions
- Author and review technical reports providing feedback and coaching on best practice, enabling associate development
- Provide skills and career path development and guidance to team members
- Work cross functionally with key stakeholder departments such as operations, engineering, supply chain and maintenance to deliver projects, resolve issues and deliver compliant outcomes
- Deploy and embed new procedures and policies ensuring compliance to requirements
- Maintenance, reporting and escalation as necessary of departmental and supporting site KPIs
- Support other functions within the department as necessary
Qualifications
- Degree or equivalent in Scientific, Engineering or Quality discipline (or equivalent working experience)
- At least 5 years experience of managing teams of professionals working in a manufacturing based quality environment
- At least 5 years experience in a relevant Quality Engineering role (e.g. pharma, med device, automotive, aerospace), where compliance in a fast paced business is critical
- At least an advanced level of operating within an ISO9001 environment and knowledge of ISO13485, 21CFR820, GxP and Pharma regulations would be advantageous
- Experience of writing problem statements and executing best practice in CAPA
- Demonstrative experience of using ISO14971 risk management principles and application
- Experienced in deploying strategy and setting and delivering objectives within a team
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