- Reference: GJ41909
- Job Type: Permanent
- Location: Galway, Galway City, Limerick
- Category: Engineering, Technical & Manufacturing
- Establishing inspection standards, plans, frequencies and test methods.
- Preparing and approving procedures, routing set-up’s and shop floor documentation. Generate and approve change requests
- Preparing/Reviewing Master Validation Plans, FMEA’s, and Control Plans.
- Make appropriate decisions on a daily basis.
- 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
- Quality representative on relevant Design/SRM Team(s).
- 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.
- Host Customer meetings and be available for regulatory audits at site and follow through with any corrective actions.
- Support customer complaint analysis and post market surveillance activities
- 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.
- 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 a confidential discussion on this role please contact Christopher O’Toole on 091-706713 or email email@example.com
For further information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie