Position: Quality Engineer – Medical Device Organisation, Galway
Responsibilities (full job spec available upon request)
Identifies and resolves complex exceptions to work assignments.
Summarizes, analyses draw conclusions, and make appropriate decisions from test results or other process related findings.
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.
Participates in Customer Complaints investigation for areas under their control.
Continually seeks to drive improvements in product and process quality.
Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making the appropriate decisions on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Knowledgeable on Risk Management, BSEN 14971 requirements.
Compiles and analyses operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
Uses knowledge of Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems and improve quality.
Gives technical guidance to Associate Quality Engineer, Technician, and Inspection staff.
Deals with suppliers, other engineering disciplines within and outside of the Site, and customers should the need arise.
Is familiar with the internal auditing process.
Qualifications and Experience:
NFQ Level 8 qualification in a STEM discipline
Minimum of 3-4 years experience in a Quality Engineering capacity.
Good technical capabilities, communication skills, teamwork abilities, and initiative.
*Strong benefits on offer such as full healthcare, pension, annual bonus*
For a confidential discussion on the role please contact Chris O Toole