Quality Engineer - Operations
The Quality Engineer - Operations is a member of the Quality Operations group.
The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They 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 Medical Quality System.
Our clients Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release.
- 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 organization’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.
- Level 8 degree in Quality / Science / Engineering.
- Experience within a similar role as Quality Engineer.
- 3+ years' industry experience in a medical device-manufacturing or pharmaceutical environment.
- Green belt problem-solving qualification preferred.
- Working knowledge of FDA/ISO/MDD 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 further information,please contact our office at 093 41932