Quality Engineer
3 weeks ago
Quality Engineer
Medical Device
Longford/Roscommon
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CPL Recruitment are once again assisting our valued client source a quality engineer X 2 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.
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 Key Responsibilities:
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·       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.
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Qualifications & Key Attributes
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·       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 aisling.murray@cpl.ie
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