Senior Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer for their site. The Senior QE will be responsible for establishing inspection standards, plans, frequencies and test methods and preparing and approving procedures, routing set-up's and shop floor documentation.
Key Responsibilities of the Senior Quality Engineer job
- Understand the requirements of design control and facilitate design review projects.
- Preparing/Reviewing Master Validation Plans, FMEA's, Risk management plans
- Addressing customer complaints and getting to source of the issue
- Process owner of NCR process - getting to source of the issue and implementing CAR. Ownership of driving this process for assigned projects.
- Drive continuous improvement and innovation from a quality perspective.
- Performing an active role in further development of the quality management system. This will involve:
- Performing internal audits to ISO and FDA requirements.
- Upgrading system elements as appropriate.
- Work with suppliers and customers on the resolution of product quality issues and quality improvement programs
- Ensure Projects quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas is compliant for assigned projects.
- Determining inspection frequencies and sampling plans using significant testing and capability studies; Implementation of Statistical Process Control in areas where needed and appropriate, analysis of data obtained.
- Support customer complaint analysis and post market surveillance activities
- Level 8 Honours Degree in Quality, Engineering or equivalent.
- At least five years' experience in Quality environment, preferably in Healthcare/Medical Device industry.
- Ability to work under strict time constraints and meet deadlines in a timely manner.
- Proven ability to work independently and under own initiative.
- Strong interpersonal and influencing skills.
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