Project Quality Engineer- Q&V

To set, attain and preserve the user requirements' information and the quality of project documentation, throughout the complete project lifecycle, cooperating in particular with Sales, Project Managers and Validation.

Main responsibilities : -

1. URS - Assist the Sales Back Office to register the User Requirement Specifications (URS) for the subsequent dispatch of the specific documents to the relevant department.

2. Documents requirements - Assist the Sales Team as main reference person for the documentation strategy during the offer phase (URS analysis / Documents proposals)

3. Deviation to requirements - Assist the Sales Team to record the list of deviations from the customer's URS.

4. Documents & projects specifications - Assure a clear and comprehensive passage of the documents obligations from the offer to the project. Assists the Validation Department in preparing the Requirement Traceability Matrix.

5. Documents scheduling & traceability - Assist Project Managers in scheduling the documentation deadlines and managing the approval documents transmissions to /from customers, throughout the project lifecycle (kick-off to FAT).

6. Documents Conformity to standards - Control documents revisions consistency, correct use of company's templates, documents conformity to the enforced EU Directives, specific market requirements, Group's SOPs.

7. Good Documentation Practices ( GDocP ) - Contributes to the development of the Groups knowledges in technical documentation management.

8. Relate all the URS documents into one offer specific register, to be managed by the Sales Team and shared with the Companys Team. This will be converted in Project URS index where the customers Purchase Order is acquired.

9. When necessary, in support to the offer preparation, reviews the customers URS with focus on the documentary and testing requirements; confirms or negotiates the list of documents (Vendor Documents List) matching up Decs typical supply with the customers demand, as far as applicable to the specific equipment.

10. When necessary, attends kick-off meetings to inform on the Documentation requirements and documents extent (offer outcome); warns the project Team about any out-of-standard documentary & testing specificity.

11. Assists validation team to create the project requirements traceability matrix in regards with design specifications and validation test cases.

12. Assists Project managers with (or coordinates) approval documents transmittals/reception.

13. Manages the Vendor Document Schedule reminding deadlines and deficiencies to the Team.

14. Can be asked to attend project meetings with customers, in the purpose of sharing the documents progress and/or explaining the documents structure.

15. Can be asked to approve project Design Documents format (not contents), confirming the compliance to internal SOPs and customers requirements.

16. Is committed to learn and keep abreast of main European Directives, international standards and industry trends. Shares his knowledge with the Team.

17. Can be asked to conduct internal trainings about the technical documentation and/or main regulatory requisitions.

18. May be required to perform other duties as per service requirements

PROFILE : -

• You Should have a degree in Engineering/ Quality being asset and have experience in an industrial environment (min 3+ years)in Technical Documentation management or Quality assurance of an engineering project consultancy group or a pharmaceutical company or oil & gas group.
• Good analysis and synthesis attitude with strong organizational & problem solving abilities.
• Naturally open-minded with strong communicative & negotiating abilities Proficient in English, both speaking and writing. Any additional languages are an advantage.
• Experienced in Microsoft Office package ( Visual Basic knowledge is an asset )Extensive knowledge of Document Controls, Document Management Systems and procedures is an asset.
• Flexibility to travel to Europe occasionally.