Quality Engineer (Operations)
Position: Quality Engineer – Medical Device Organisation, Galway
Responsibilities (full job spec available upon request)
- Identifies and resolves complex exceptions to work assignments.
- Summarizes, analyses draws 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
Please get in touch to find out more information
091 706 718