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Title: Senior Quality Engineer
Purpose of Job:
Responsible for providing quality engineering support for all aspects of Bought in finished Goods Business, a dedicated resource that is responsible for developing and managing the relationship between the company and their contract manufacturing partners in order to drive quality and will be responsible for managing all Quality aspects of the relationship and will partner and be a consultant and advisor to internal customers and business functions, within the company.
Major Roles & Responsibilities:
- Ensures major nonconformance’s and trends are escalated to management and prioritized 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 (GSC/QA).
- Change control – Review and approve supplier change requests as well as company initiated 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.
- Proven leadership skills in Quality Systems & Regulatory
- 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.
For a confidential discussion and more information on the role, please contact David Lennon on 090 64 78104 or email firstname.lastname@example.org