Quality Engineering Manager

Location: Tipperary [Tipperary]

Salary: €0 - €0

Ref: 890321

Type: Contract

Job Description:

Preventing the use of non-conformance materials in the process
Preventing the release to stock of product not meeting all specifications
Where appropriate, to refer dispositional of non-conforming materials to Global Quality and/or Regulatory Affairs
The Process Quality Manager will report on the performance of the Quality system to the Quality Manager
respective Product Management teams and as required to Management with executive responsibility
The Process Quality Manger can act as the designated stand in for the Quality Manager who is the Management representative when required

Roles / Responsibilities:

To oversee Product Quality that meets Customer requirements
To assess & challenge established Quality Systems and Quality methods with an objective to improve overall system effectiveness, reduce product and process risk and improve quality system efficiencies
To apply both a Lean and Six Sigma approach in developing new or revised systems
Development of efficient and compliant systems that meet both business needs and regulatory requirements
Drive quality and cost improvement initiatives in combination with Process Quality Engineering, Process Engineering and Operations
Conduct problem solving investigation, root cause and risk reduction analysis across processes
Support and risk mange process change initiatives to ensure appropriate level of validation and verification
Work in partnership with Operations and Process Engineering to drive quality and cost improvement initiatives

Skills / Experience:

Preparation and reporting on the performance of the Quality system to Management with executive responsibility
Ensure quality systems are robust to ensure acceptable product quality is produced and releasedFollow Standard Operating Procedures at all times
Follow required applicable regulatory standards as required
Ensure compliance to the QMS
Following Personal Hygiene Rules as defined in the GMP Training Programme and notify area supervision of any health conditions which may affect the quality of product
Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner

Education / Professional Qualifications:

Third level qualification, ideally in Engineering or Science
5+ years experience in Healthcare or Electronics industry
Strong analytical skills with good knowledge of applied statistics and process control systems
Knowledge of Six Sigma and Lean tools
Self motivated with ability to lead a core team to meet the above objective.
Must be familiar with the regulatory requirements of FDA and/or ISO
Decisive, good communicator, self-motivated, have record of achievement and be a good team member

Please contact Trefor Murphy for further details treformurphy@brunel.ie

 

Tags:

Tipperary, Quality Engineering Manager