Process Engineer

This job has now expired please search on the home page to find live IT Jobs.

Reporting to the Manufacturing Manager, as Process Engineer you will responsible for supporting production management in improving the efficiency, quality and safety of the Manufacturing environment.

You will provide support to the Manufacturing department to investigate deviations, identify root cause and determine corrective and preventive actions to be taken. You will also work with a cross functional department team to prevent recurring deviations, drive process improvements which will prevent the occurrence of deviations and create and maintain metrics governing deviation rates and in particular recurring deviation metrics. You are responsible for researching and instigating new projects which lead to process/ product improvements. Strong analytical skills in problem solving is key to this position.

Key responsibilities:

1 Perform manufacturing deviation investigations and root cause analysis within the agreed investigation timelines. Draft reports to document related activities.

2 Use of problem solving tools to perform thorough investigation of non-conforming events. Ensure that the appropriate root cause analysis tools are used when leading NCE investigations if applicable.

3 Create, maintain and present metrics governing deviations.

4 Monitor non-conformance trends for CAPA escalation.

5 Create and drive change controls required for effective CAPA implementation or CIP projects.

6 Draft and route standard Operating Procedures as required. Identification and training of new lead investigators.

7 Responsible for driving effective CAPAs for compliance actions within the agreed timelines.

8 Responsible for driving effective CAPAs for internal and external audit findings within the agreed timelines.

9 Drive Lean Manufacturing and CIP projects to conclusion.

10 Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.

Ideally you will possess:

* Knowledge of Quality Systems regulations including ISO13485.

* Strong technical abilities.

* Ability to work on own initiative and as part of a team.

* Excellent problem solving skills and competence on all Microsoft office applications.

* Ability to determine, influence and action appropriate corrective and/or preventive action.

* Report writing expertise, excellent communication skills and highly developed people skills.

* Knowledge of statistical methods.

Education

Minimum: Bachelor degree in Engineering/ Physics or related discipline

Preferred: Masters/ PhD degree in Engineering/ Physics or related discipline

Experience

Minimum: 3 - 5 years working at Engineer level within a regulated or medical device environment.

Preferred: 5+ years' experience at Engineer or Senior Engineer level within a regulated or medical device industry.

Sthree UK is acting as an Employment Agency in relation to this vacancy.