Quality Engineer - Medical Device New - Longford

Quality Engineer

Medical Device

Longford/Roscommon

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

• 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.

• 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