A medical device manufacturing company located in Oranmore, Galway, is looking to recruit a Quality Engineer on a one year fixed term contract (with a view to permanent).
Salary: 40-53K depending on experience
Experience: 2 years plus
Successful candidate will be responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. The creation / development of procedures, manufacturing workflows, validation of required processes, developing inspection control plans, analysing quality trend data and taking appropriate action; supporting production on all quality related issues; investigating customer complaints; and ensuring an effective and robust quality system which complies with all relevant regulatory requirements.
Duties & Responsibilities
- Formulates procedures, specifications, and standards for products and processes.
- Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
- Develops and implements corrective/preventative action plans.
- Collects and analyzes data for gauge and product evaluation.
- Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
- Ensure all validation activity is effective and documented in a compliant manner.
- Complete in-depth investigations into, product non-conformances, customer complaints and implement corrective and preventative actions, as appropriate.
- Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
- Ensures that suppliers have necessary information and facilities to deliver quality products to the company.
- Certifies product builders to ensure they have the required skills to complete their operation.
- Third Level Degree in Quality or Engineering field
- 2 years relevant experience in a relevant quality technician role.
- Excellent communication and influencing skills.
- Microsoft Office Suite.
- Understanding of QSR/ISO regulations
- Risk assessment skills using FMEA methodology
- Product testing methods, and able to use hard gaging and optical comparators.
- Knowledge of statistics, process control, and process capability.
- Demonstrated NCR / CAPA experience
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Facilitates team efforts on quality engineering projects.
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple stakeholders
- Demonstrated history of taking initiative, meeting commitments and assisting in the creation of new tools or solutions to achieve business results.
- New Product Introduction / Product transfer experience
- Process / software validation Experience
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