Validation Engineer

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Overall responsibilities

The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally. The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products /processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

Position duties and responsibilities

This position will be specifically dedicated to execute TMV activities (Test Method Validation) of the gages in production. Below are some of the tasks included:

· - Test Method Validation planning following the open projects

· - Technical Writing of the Test Method Validation documents (Plan, Reports)

· - Execution of the Tests in partnership with Inspection and Manufacturing departments

· - Training of the employees for all TMVs completed

· - Provide support for problem solving in case of test failure

Extended duties (if applicable)

Additional tasks can be provided following projects demand.

Job profile

Education Requirements:

A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.

Experience:

- Generally requires 2-4 years related experience.

- In depth knowledge in mechanical production and mechanical drawing reading

- Experience working in both an FDA and European regulatory environment is preferred.

- This position will require relevant experience working in manufacturing/operations.

- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is

preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

- Experience with a proven track record of implementing appropriate risk mitigation.

- Strong knowledge of statistical software packages is preferred with the ability to preview,

graph and analyze data and be able to present data that facilitates/drives decision making.

- The ability to perform "hands on" troubleshooting and problem solving is preferred. The

ability to think on the feet and providing sound judgment is highly desired.

- Good technical understanding of manufacturing equipment and processes is required.

- Understanding of the NPI (New Product Introduction) process and Process Validation

expertise is preferred.

- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

- Demonstrated project management and project leadership abilities are preferred.

Minimum Language required

German: Very good

English: Very good Conatct: Isabel Rieger +442077495631Michael Bailey International is acting as an Employment Business in relation to this vacancy.