Telephone: 086 8395533
Senior Quality Engineer – NPI
Our client, a medical device company in Galway is currently looking to recruit a Senior Quality Engineer – NPI for their site.
Key Job Responsibilities:
- Supervision and mentoring of Quality team members.
- Establishing inspection standards, plans, frequencies and test methods.
- Preparing and approving procedures, routing set-ups and quality documentation.
- Preparing/Reviewing Master Validation Plans, FMEAs, and Control Plans.
- Makes appropriate Quality decisions on a daily basis.
- Address customer complaints and investigation root cause.
- Process owner of Non-conformance investigation process – root cause investigation and implementation of corrective actions.
- 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
- Quality representative on relevant Design/SRM Teams.
- Ensure Projects quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas are 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.
- Host Customer meetings and audits and supports regulatory audits and any actions.
- 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.
- Ability to work as part of a team and meet targets/goals efficiently.
- Ability to supervise and mentor Quality team members.
- PC skills including standard office packages as well as ability to understand and learn customized computer software programs.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
For further information on this Senior Quality Engineer – NPI role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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