Quality Engineer S010913

Quality Engineer

RecruitmentPlus has an excellent opportunity for a Quality Engineer to join our client‘s team, based in Citywest, Dublin. The successful engineer will work closely with their engineering team to ensure manufacturing and production are kept to high standards.

Role/Responsibilities:

• Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance.

• Document control and review/approval of controlled documents.

• Change management and review of change controls.

• Investigation and CAPA management, including robust root cause analysis.

• Complaint management and performance of complaint investigations.

• Supplier quality management and performance of supplier audits as appropriate.

• Internal audit program and performance of internal audits.

• Training programs: conduct training when needed.

• Implementation of Quality Risk Management in relevant aspects of the QMS.

• Management Review.

• ISO certification and maintenance.

• Perform Risk Assessments.

• Lead and/or support the oversight of product realisation and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.

• Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.

Skills/Requirements:

• Bachelor‘s Degree in a Technical Field or demonstrated work experience to a similar level.

• Regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).

• Experience in a previous quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.

• Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in plant systems.

• Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment.

• Demonstrated understanding of Lean Manufacturing concepts.

• Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project.

• Knowledge of sterility and managing a sterile program.

• ASQ certifications (e.g CQE, CQM, CQA) desirable.

Benefits

• Competitive salary.

• Pension.

• 21 days annual leave.