Quality Engineer
Medical Device
Longford/Roscommon
CPL Recruitment are once again assisting our valued client 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 and ISO 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.
·Provides manufacturing support and Quality expertise in relation to Manufacturing issues and
product disposition
·Performing 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.
·Supporting and representing the site during external audits and carrying out Internal Audits.
·Trending and track of quality data to support quality improvements across the business.
·Supporting 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 / validations.
·Excellent interpersonal, communication, influencing, and facilitation skills
For a confidential discussion, reach out to e