Quality Assurance Engineer

Job Title: Quality Assurance Engineer – Permanent – West Limerick!

Job Summary: We are looking for a Quality Assurance Engineer for our client based in West Limerick. The Quality Assurance Engineer will be responsible for providing validation and risk management support for the development of new and existing products.

There will also be a strong focus on continuous improvement activities to improve process efficiency, product compliance and control.

This ideal candidate will have experience in a regulated manufacturing environment and will have experience conducting quality audits and CAPA systems desirable.

Requirements:

• Adhere to all Quality and Safety requirements on site and supporting Quality and Safety initiatives as required.
• Define, interpret, and classify critical quality characteristics for new products and processes.
• Support supplier development and supply assurance for designated components and materials.
• Produce and maintain raw material control records, manufacturing batch sheets and equipment cleaning forms at appropriate stages during the development and implementation of new products/technologies/processes.
• Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance and participate in continuous improvement activities such as Lean and Six Sigma.
• Participate in design and process evaluations including development of material and product specifications, test methods and risk analysis (e.g., DFMEA, PFMEA).
• Produce and maintain raw material control records, manufacturing batch sheets and equipment cleaning forms as required for existing products/technologies/processes.

Qualifications:

• Minimum of 3-5 years’ experience in a regulated manufacturing environment.
• Relevant qualification in Science or Engineering.
• Knowledge of process, test, systems, software and equipment validation.
• eQMS experience and ETQ desirable.