- Reference: GY46433
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
Excellent opportunity to join a global leader that designs and manufactures minimally invasive delivery and access devices serving medical device original equipment manufacturers (OEMs). Headquartered in Galway, Ireland, my client has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.
The Operations Quality Engineer is a member of the Quality group.
S/he is, responsible for Quality within their prescribed area of functional responsibility.
S/he will be working as part of a team to maintain high quality / performance standards on all Medical products.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the company’s Medical Quality System
- Overall responsibility for production GMP standards and compliance.
- Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
- Establishing inspection standards, plans, frequencies and test methods.
- Establishing and maintaining FMEA’s.
- Preparing and updating Operations procedures and associated documentation.
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Develop strong links with customer organisation’s and other project stakeholders.
- Quality review of responsible area validation documentation.
- Performing an active role in further development and continuous improvement of the quality management system.
- Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.
- Other duties as assigned from time to time.
Skills, experience and qualifcation requirements:
- Degree in Quality or Degree in Science / Engineering.
- Experience within a similar role as quality engineer.
- 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
- Working knowledge of FDA and ISO Quality systems for Medical device companies.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com