Job Title: Quality Systems Engineer.
Are you a detail-oriented professional looking for a challenging role in quality assurance?
We are seeking a highly motivated and organized Quality Systems Engineer to join our team in Galway, Ireland.
This is an exciting opportunity to contribute to the success of our company by leading process/procedure definition and maintaining a continuous flow of high-quality products to our customers in a contract manufacturing environment.
As a Quality Systems Engineer, you will be responsible for supporting some of our product families in both the Med-tech and Industrial sectors, liaising with Production, Engineering, Supply Chain, and Customer contracts reporting into our Quality Manager.
Key Responsibilities:
- Manage performance of reports
- Customer liaison for quality escalations and daily quality issues ensuring measured, developed, and timely responses to the customer
- Support the change management process and customer requests as appropriate
- High level of competence using relevant corrective action systems (e.g., CAPA)
- Create concise and accurate technical reports, communicate results, and manage subsequent analysis queries
- Continually seek to drive improvements in product and process quality
- Create and evaluate metrics to drive the quality improvement processes
- Own, maintain, and report timely and accurate KPI's
- Create, update, procedures, and work instructions
- Manage and maintain the NCMR database and report weekly to the customer
- Using appropriate statistical techniques to monitor process performance (e.g. SPC, Minitab, Ppk, Gage R&Ranalysis, sampling techniques)
- Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg. FMEA's, control plans)
- Ability to design tests, evaluate results, and recommend solutions to improve the processes associated with our manufacturing. Requirements: Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485) Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format.
The ideal candidate should have a Bachelor's degree in related field and 6 years or more experience in a manufacturing environment within a Quality function Experience in a Med-tech environment is essential Experience of Six Sigma quality methods would be a distinct advantage.
A global and collaborative culture with strong leadership imperatives to foster your growth and professional opportunities A sustainable culture where we provide opportunities for employees to give back to the community