Quality Assurance Engineer
3 days ago
Job Description:
Russell Brennan Keane is a leading Irish company seeking a highly skilled Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for supporting all validation activities associated with the successful qualification of new tools and product introductions.
- Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements
- Generate risk assessments, covering cleaning, validation, and process review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols
The successful candidate will have excellent interpersonal, communication, influencing, and facilitation skills, along with a minimum of two years' experience as a Validation Engineer within an Injection molding or medical manufacturing environment.
Key Responsibilities:
- Support the development and implementation of solutions to sustain and improve the QMS
- Maintain and support compliance to ISO 13485 and ISO 14001 systems standards
- Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented
Required Skills and Qualifications:
- Third-level qualification in Engineering, Polymer Science, or equivalent
- Experience in statistical analysis (Minitab) and SPC/validations
- Minimum of two years' experience as a Validation Engineer within an Injection molding or medical manufacturing environment
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