Senior Quality Engineer

CREGG are currently hiring a Senior Quality Engineer to work onsite with a leading medical device multinational client in Galway Call Stephen Coen 0861030418 Email: stephencoen@cregg.ie

Job Description:

• 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

Key Skills & Experience

• 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