Senior Quality Engineer
Salary: €60k - €65k plus benefits
Standard working hours - 8:30am - 5:30pm Monday to Thursday, 8:30am - 1:30pm Friday
- 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.
- Communicates with stakeholders globally to ensure alignment, resolve problems, and share best practices.
- Leads major issues, when appropriate.
- Facilitates external regulatory and customer audits.
- Lead & drive programs and projects that deliver ‘best in class’ manufacturing metrics.
- Change control
- 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