Quality Engineer

Summary:
A global healthcare company based in Waterford is seeking a Quality Engineer to join its team. The incumbent will assist in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. This role will ensure that performance and product quality conforms to established company, customer and regulatory requirements. The quality engineer will assist in the review, analysis and reporting on quality discrepancies related to assembly and process.

Responsibilities:

• Support release of assembly batches including offline testing, paperwork, stratified samples management.
• Update and creation of work instructions as required.
• Support of validation and metrology activities.
• Drive changes in process to minimise risk of error in paperwork, sampling or testing.
• Work with team leader, QA Inspectors, line Co-ordinators and batch release specialist to ensure all steps of batch completion and release are defined and executed consistently.
• Be point of co-ordination for all quality issues between automation and moulding.
• Set-up process to log, track and resolve issues seen.
• Drive specific issues to resolution.
• Determine opportunities to pro-actively drive product quality improvement though process or procedural changes.
• Support all company safety and quality programs and initiatives.
• Ensure ongoing compliance with GMP in all practices, recording of events and processes.
• Ensure compliance with all learnings from all GMP training events.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Qualifications & Experience:

• Level 8 Degree in Science / Engineering (Mechanical / Electronics / Chemistry) or related discipline or Level 7 in same disciplines coupled with 2/3 years relevant quality experience in a GMP environment.
• Excellent IT, Communication, Interpersonal and presentation skills.
• Ability to work off own initiative and as part of a cross functional team.