Senior Quality Engineer (Operations)
Senior Quality Engineer (Operations), Galway.
Reporting to the Quality Manager, the Operations Senior Quality Engineer is a member of the Operations Quality group. The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance with the company's Quality System. The focus of the role is to supply high-quality medical devices and components to deliver an extraordinary customer experience
Key Duties (full spec available upon request)
- To deliver on all KPIs that help the business achieve its goal.
- The Operations Senior Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
- Establish and maintain risk management principles and methods throughout the product realization process in compliance with the company’s Quality Management system and ISO14971.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Offer quality guidance to a team of Quality Technicians & Engineers in support of the day-to-day manufacturing operations.
- Develop strong links with customer organisations and other project stakeholders.
- Quality review of responsible area validation documentation.
- Investigation of root cause and implementation of effective corrective actions to prevent the re-occurrence of compliance issues.
- Overall responsibility for production GMP standards and compliance.
- Establish inspection standards, sampling plans, and test methods.
- Prepare and update Operations procedures and associated documentation.
- Support customer audits and surveillance/accreditation audits.
- Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.
- Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
- As per client policy, all applicants must have a Level 8 degree
- 5+ years working as a Quality Engineer in a medical device industry
- Strong knowledge of Quality Systems and measurement techniques
- Strong CAPA, Audits, ISO experience along with being to demonstrate excellent problem-solving skills
What you will receive in return
- A competitive package that includes; annual bonus, full family healthcare, pension, access to Health & Wellness incentives,
- Salary is DOE
- Fantastic opportunity to join a global organisation that is known for its high delivery of products and it's career progression with employees
Please contact Elaine Dolan for more information:
091 706 718