Quality Engineer - Medical Device

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 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

For a confidential discussion, reach out to [email protected]e