Telephone: 086 0449473
Senior Quality Engineer Westmeath
Our client, a medical device company in Westmeath are currently looking to recruit Senior Quality Engineer.
Report to the Director of Quality.
- Ensure major non-conformance’s and trends are escalated to management and prioritised commensurate with risk.
- Identifies and effectively issues SCARs where quality issues are identified in relation to product received from suppliers.
- Supports the completion of risk assessment and validations as applicable.
- Conducts device evaluations related to product issues and performance.
- Develops quality presentations, status reports and measurement processes in support of the Bought in Finished Goods business
- Communicates with stakeholders globally to ensure alignment, resolve problems, and share best practices.
- Leads major issues, when appropriate.
- Facilitates external regulatory and customer audits.
- Serve as the QA focal point for the Bought in Finished Goods relationship.
- Lead & drive programs and projects that deliver ‘best in class’ manufacturing metrics.
- Implement continuous improvement processes with Bought in finished Goods Suppliers in terms of product quality and service
- Leverage business knowledge & supplier management competencies from within (GSC/QA).
- Change control - Review and approve supplier change requests
- Monitor and control progress of supplier quality projects, ensure sound application of engineering, provide project reviews where necessary.
- Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of CGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Qualification in Quality, Science or Engineering, and/or relevant experience.
- Five (5+) years’ experience in a Medical Device environment.
- Good working knowledge of Statistical techniques and methods.
- Problem solving skills for developing creative solutions and meeting objectives are required.
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
- Working knowledge of Oracle/SAP/ERP system and Business Objects software program.
- Excellent analytical ability
- Ability to work well under deadlines and pressure
- Communication skills
- The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
- Proven leadership skills in Quality Systems & Regulatory
For further information on this Senior Quality Engineer role in Westmeath please contact Orla Crowley Healy on 086 0449473/ Talent@hero.ie
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