Our client a major multinational here in Galway are looking to hire a Senior Quality Engineer (Process Validation) on an initial 12 month contract.
- Provide Quality Engineering support, with a focus on process validation, to product development, technology transfer, improvement projects and/or core teams.
- As part of a cross-functional team, support the execution of process validation activities together with technology transfers from other locations.
- Provide quality focus and technical support for task teams.
- Support the characterization and risk assessment of manufacturing processes and associated equipment.
- Work within project teams to establish process controls that ensure the safety and efficacy of the product.
- Providing on-going communication, information transfer and record keeping in support of department and core-team objectives and metrics.
- Understand product construction, features and uses at a competent level in order to make decisions on product acceptance standards within their scope of responsibility.
- Use and establish analysis techniques and other quality control tools to aid decision – making.
- Functioning effectively as a quality engineering extended product development project team member as part of a wider cross functional team, developing strong partnering relationships with these groups, at both the manufacturing and design sites.
- Participate in and initiate job-related training courses
- Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
- 5-8 years’ experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
- A good working knowledge of process validation is required.
- A good working knowledge of equipment validation and software validation would be beneficial.
- High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.
- Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.
- Technical writing skills.
- Ability to take initiative, to organize and prioritize own work and proactively contribute to project level strategies and planning.
- Effective time management skills.
- Able to analyze and chart data using MS Excel or Minitab
- Previous Quality Auditor experience is desirable, or certification is an advantage
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717