Project Quality Engineer

il y a 12 heures

Le PontdeClaix, France BD Temps plein

**Job Description Summary**:

- Reporting into the Design Assurance organization, the WW Quality Engineer is an extended team member representing WW Quality on new product development projects and/or a team member for life cycle management/sustaining engineering projects.
- He/she plans and delivers Quality Engineering activities to secure milestone/commitment achievement. He/she sets priorities for self and contribute to team planning.
- He/she is responsible for combining design control expertise, problem-solving approaches and analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to risk management, process validation and control strategies.
- In addition, this position plays an active role in the processes to ensure products meet customer/patient needs and quality standards consistently with both corporate and unit policies, while meeting all design control and other regulatory applicable requirements.

**Mission**
- Provide Quality Engineering support to assigned R&D or WW Operations projects:

- Evaluate customer requirements and applicable quality standards
- Ensure design control activities are satisfied
- Lead product related risk management activities
- Initiate change control submission and generate quality answer with the support of R&D and Engineering
- Ensure Worldwide Validation plan related to the product/process design is established and process validation activities are completed
- Ensure supplier qualification plans have been defined and executed
- Ensure appropriated robustness of test methods used in project activities (test method validation or equivalency when used in different sites (Plant, supplier )
- Define or update the product & process WW control strategy
- Release product under development
- Ensures quality conduct of project, including design, data summary, interpretation and report generation
- Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.
- Liaise with Manufacturing Plants and SMO

**Primary Work Location**: FRA Le Pont-de-Claix Cedex

**Additional Locations**:
**Work Shift**:

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