Quality Project Engineer for Design Assurance - Le Pont-de-Claix, France - BD

Entreprise vérifiée

Le Pont-de-Claix, France

il y a 3 semaines

Posté par:

Sophie Dupont

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Description

Job Description Summary:

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Please be aware that our home office policy enables our employees to come on site twice a week
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Reporting into the Design Assurance organization, the WW Quality Engineer is one of the team members representing WW Quality on new product development and/or life cycle management/sustaining engineering projects.
As a Quality engineer in the Core Team, he/she plans Quality Engineering activities to secure milestone/commitment achievement. Sets priorities for self and contribute to team planning.
As a Quality Engineer, he/she is responsible for combining design control expertise, problemsolving approaches and analytical skills to support projects and activities using quality engineering skills including but not limited to risk management, process validation and control strategies.
In addition, this position will play 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.

Activities

Plans Quality Engineering activities to support assigned R&D or WW Operations projects/activities:
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 driven
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 problemsolving sessions for nonconforming 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
As a Quality Engineer, provide Quality Engineering support to internal organizations, regulatory bodies and customers (ex: audits, requests ).
Continuous learning and improvement: Actively seeks training to improve skills. Ensures technical lessons are reviewed, learned, and disseminated. Supports continuous improvement of current products and practices to support the business improving quality and customer experience
Ensure product compliance and implementation of PS global procedures and standards for assigned Quality Engineering activities

Profile

Typically requires an
Engineer/ master's degree in Quality management or Science*:
Minimum of
3-5
years' relevant experience like high volume and regulated industrial environment
Healthcare/Pharmaceutical/ Biologics/Medical Devices experience is a plus
Thorough understanding of industry regulations/standards
: ISO 13485, QSR, GMP:
Knowledge of design control principles and related disciplines
Understanding of statistical methods for Quality Assurance
Knowledge of the sixsigma process methodology
Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
Knowledge and experience in manufacturing
Good written and oral communication skills including in
English language