Quality Engineer (Value Stream)

  • Reference: CJ46203
  • Job Type: Permanent
  • Location: Leinster, Wexford
  • Category: Engineering, Technical & Manufacturing

Job Summary:

 

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.
  • Validations.
  • 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 eloisa.ruiz@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Eloísa Ruiz

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  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
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