Ww Project Quality Engineer
il y a 2 semaines
**Job Description Summary**: The Project Quality Engineer is responsible to ensure that all aspects of the product/process development cycle have been addressed.
He/She works in multifunctional Project Teams as Quality Core Team Member. He can act as well as WW Quality referent in Clusters.
He/She is responsible for supporting new product/process development and product/process maintenance thru the use of the Quality Engineering skills. He/she is responsible for all Quality Management activities during the four steps of a project
- Definition phase
- Development phase
- Qualification phase
- Launch phase
Provide Quality Engineering support to all assigned projects, manufacturing facilities and suppliers:
- Evaluate customer requirements
- Initiate product development notification (change control) and generate quality answer
- Develop quality plans
- Lead risk management activities (FMEA)
- Ensure design control elements are satisfied
- Ensure process validation activities are completed. Write World wide Validation plan related to the projects
- Ensure supplier qualification plans have been defined and performed
- Evaluate test methods used in project activities
- Define control strategy for new product
- Release product under development
- Conduct quality functional reviews
- Support Post Market Surveillance according to approved plans
- Ensure product compliance : establish Quality Statements and answer to customer and customer questions
Ensure, as WW Quality function, that technology transfer requirements are satisfied
Develop close relationship with other quality functions: Plant Quality Assurance, Supplier Quality Assurance, Customer Quality Assurance and Technical support as well as all the other support functions: WW Engineering, Manufacturing, Supply chain, R&D, Marketing, Regulatory Affairs and Medical Affairs.
Assess project activities for quality assurance and compliance
Develop and implement quality improvement programs
Assist / conduct Failure Investigations and problem solving sessions
Quantitative dimensions:
From 1 to 20 projects managed at the same time depending on the complexity
Worldwide role
Around 300 customers
**PROFIL**
Master degree in mechanical, biochemistry, material, or equivalent.
1- 2 years industry experience** **(Healthcare/Pharmaceutical/Biologics/Medical Devices is a plus)
Required mandatory skills for job function
- General understanding of Statistical Methods for Quality Assurance
- Knowledge of Six sigma Methodology, Process Validation, experience in FMEA/Risk Management
- Understanding of industry regulations/standards: ISO 9001, ISO 13485, QSR, GMP
- Good written and oral communication skills
- Fluent in English
- Excellent problem solving and analytical skills
- Strong interpersonal skills
- Rigor and good organization.
Other specific competencies
- Influence other: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion skills. Remain open to be persuaded when appropriate.
- Promote work in multidisciplinary teams.
- Dealing with ambiguity: demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change.
- Ability to handle multiple projects simultaneously with a high level of autonomy.
- Customer focus: Develop understanding of customer needs to identify applicable internal and external quality standard
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
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