- Reference: CJ43683
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Engineering, Technical & Manufacturing
Description: The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
Duties and Responsibilities:
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- ISO 14000
- Ensuring continued compliance with DMR
- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends.
- Areas for Improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis andchanges to the system.
- Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
- Engineering Change Order (ECO).
- Request for Corrective Action (RCA).
- Material Review Request (MRR).
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- Project meeting attendance as required.
- Attend and participate in daily cell meetings.
- Preparation of information for KPI and Management Review meetings.
Skills and knowledge:
- Ability to communicate and work with people inside and outside the department.
- Knowledge of engineering theories and methods.
- Good technical report writing skills and rigorous attention to detail.
- Engineering or science degree preferably with Quality Engineering included.
- 3-4 experience in Quality.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com
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