Creganna-Tactx Medical
Galway, Ireland
Description
The Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations 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 Creganna Tactx Medical products.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Creganna Tactx Medical Quality System.
Key Job Responsibilities:
- 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.
Job 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.