The person has responsibility for the development and execution of plans to continuously improve and optimize product quality and process yield.
This requires the use of process characterization and optimization using designed experiments, problem solving and decision making tools.
Main Duties and Responsibilities:
- Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
- Ensure all process developments and improvements meet the Quality Management System requirements (ISO 13485, FDA & JPAL).
- Strong analytical approach to problem solving to deliver innovative solutions.
- Lead and work in cross functional teams.
- Demonstrate strong leadership and a clear identifiable work ethos within the team
- Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc).
- Project Management – Accurate planning, timely delivery and reporting for all project deliverables.
- Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
- Develop and maintain Behavioural Standards in line with company standards and policy.
- Work with team leader to develop and implement strategic engineering Goals & Objectives.
- All employees are responsible for the Environmental and Health & Safety effects of the work that they perform
- Keep up to date on new developments and technologies in assigned disciplines and present on new ‘Best Practice’ methodologies, procedures, processes and equipment to the company in a proactive manner.
Education and Experience:
- Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering with minimum 4 years experience.
- Relevant experience with statistical process control and capability analysis required.
- Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
- Ability to work on own initiative.
- Good interpersonal and communication skills with proven leadership abilities.
- Familiarity with manufacturing and validation in a regulated (FDA or IMB) environment an advantage.
- Must be flexible and able to manage multiple priorities simultaneously.
- Experience of lean concepts such as 5S and standard work would be an advantage
For further information on this Senior Process Engineer role in Galway please contact Anna on 0864667369 / firstname.lastname@example.org
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