Job Description
Quality EngineerMedical DeviceLongford/RoscommonCPL Recruitment are once again assisting our valued client to source a Quality Engineer to join their team. The site has undergone major investment and expansion and thus the need to hire you. You will be working with a very friendly and experienced team that have a wealth of experience in the leadership team. They have currently two open roles and will consider candidates from a quality technician level wanting to step up and a more experienced option (3-5 years plus).Prior medical device experience would be highly regarded.This role is due to growth and expansion and so you may see the same post as a few months back.Key Responsibilities:Developing and implementing solutions to sustain and improve the QMS.Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.Interface with customers on new products, quality issues, and process qualifications.Develop and implement process control programs to ensure customer requirements are met.Carry out process validations and qualification on products.Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.Co-ordinate NCR / CAPA process to ensure timely resolution and closure of issues.Lead training activities on quality procedures, e.g., compliance, GMP, audit prep, and GDP.Support and represent the site during external audits and carry out internal audits.Trend and track quality data to support quality improvements across the business.Support environmental, health, and safety requirements, training, and regulations.Perform additional duties at the request of the direct supervisor.Qualifications & Key Attributes:Third level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.Experience in statistical analysis (Minitab), SPC, and validations.Excellent interpersonal, communication, influencing, and facilitation skills.For a confidential discussion, reach out to aisling.murray@cpl.ie #J-18808-Ljbffr