- Reference: CJ46203
- Job Type: Permanent
- Location: Leinster, Wexford
- Category: Engineering, Technical & Manufacturing
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:
- Areas for Improvement to senior management.
- Engineering Change Order (ECO).
- Request for Corrective Action (RCA).
- Material Review Request (MRR).
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- ISO 13485
- FDA QSR
- ISO 14000 and 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.
- Review and propose changes to sampling plans based on trend analysis and changes 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.
- 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.
Minimum education and experience requirements:
- Engineering or science degree preferably with Quality Engineering included.
- Minimum of 3 years experience in a regulated environment
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email firstname.lastname@example.org
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