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.
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.
· 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
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