Manufacturing Quality Engineer

18 Oct 2016
16 Nov 2016
Contract Type
Manufacturing Quality Engineer
Based in Wiltshire

Job ref: AZ/36320

Salary: c.£35,000

To work in project teams responsible for all activities dealing with validation, risk assessment, test methods validation and statistical assessment of data.

To ensure regulatory requirements are met and that internal procedures are worked to and these activities give added value to the product.

With a background in statistical analysis (ideally six-sigma green belt), the person will also support plant engineering with Capacity Expansion, Continuous Improvement and Lean projects. They support manufacturing to continually improve Production processes in terms of efficiency, utilisation and waste reduction.

Responsible for quality related activities within project plans (New Product Introduction, Capacity expansion, Continuous Improvement or Lean projects) are completed fully to agreed timescales and within budget.
Compiling Validation Plans with required change control and validation strategy as part of overall project plans.

Defining test requirements; coordinate development & validation of test method;
Develop sample plans, inspection regimes for product validation and manufacturing.
Statistical analysis of data in process development and validation stage.
Define required controls for further process monitoring
Creating the required controlled documentation and structures.
Coordinate new material introduction within the project.
Writing validation protocols and reports.
Carry out the validation of processes, products and IPV.
Carrying out internal and supplier audits.
Contributing to the site audit plan.
Assessment of data for presentation with conclusions and recommendations.
Effective communication with other sites (i.e. design authority)
Supporting plant projects to improve efficiency of production processes.
Reducing scrap levels of production processes.
Identifying the activities required to improve manufacturing processes.
Providing Quality data and analysis to review meetings

As product / process expert, support when required Shop-Floor QA for :
investigating the reasons for non-conforming product and support the release of blocked stock by QA group
Investigating and delivering insights to complaints for Complaints Engineer to write the reports within required time scales.

Additional information on competencies required
The person needs to be self-motivated and able to communicate to Associates at all levels. They need to have a good attention to detail, well organised, methodical in completing documentation and following procedures, able to handle multiple activities concurrently, flexible to suit manufacturing requirements. Some travel to other company facilities and customers will be necessary (up to 20% of the time)

At minimum, worked in a quality function with an understanding of quality systems
Previous Experience of working in a highly regulated industry
Experience of working in high volume production environment
They need to be a competent user of Microsoft packages

Medical device industry experience (FDA, ISO 9001, 13485)
Ideally has SAP, QDMS and Minitab experience.
Degree Level Education and six-sigma qualified (green belt/black belt)
Knowledge of injection moulding and automated assembly process

Has at minimum an A level standard of education and been trained in statistical techniques (ideally six sigma qualified) and has a knowledge of validation methods.

For EU roles, candidates must be eligible to work and live in the European Union.
Proof of eligibility will be required with your application.

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