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Quality Project Engineer for Design Assurance
Il y a 4 mois
**Job Description Summary**:
- ** Please be aware that our home office policy enables our employees to come on site twice a week.**:
- 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, problem-solving 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 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
- 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 six-sigma 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
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
**Additional Locations**:
**Work Shift**:
