Worldwide Quality Engineer

BD (Tissuemed Ltd); Le Pont-de-Claix; Sur place; EUR 55 000 - 65 000; Plein temps

Résumé du poste

A leading medical technology company in France is seeking a Quality Engineering Staff Engineer to lead quality activities in new product development. The ideal candidate will have expertise in ISO 13485, design control principles, and risk management. You will ensure products meet quality standards while overseeing project management. A competitive salary ranges from €55,000 to €65,000, with opportunities for professional growth.

Qualifications

• Confirmed experience in quality systems, validation, FMEA, and risk management.
• Able to independently lead multiple projects from design initiation to implementation.

Responsabilités

• Translate the project strategy into a quality plan covering all activities.
• Lead the execution of the quality plan to ensure project success.
• Initiate change requests and define the quality response with R&D.

Connaissances

Deep understanding of ISO 13485

Strong command of Design Control principles

Advanced knowledge of statistical quality assurance methods

Solid understanding of manufacturing processes

Excellent written and verbal communication skills

Fluency in English

Experience in quality systems and risk management

Description du poste

Job Description Summary The worldwide Quality Engineering Staff Engineer is the core team member representing worldwide Quality on medium to high complexity new product development and/or life cycle management/sustaining engineering projects. You plan and lead Quality Engineering activities to secure turning point/dedication achievement, often coordinating other extended quality SMEs (ex: Plant, Validation, Sterilization, Supplier). Sets priorities for self and contribute to team planning. You are responsible for combining design control expertise, problem-solving approaches, and analytical skills to support projects/complex activities using strong 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.

Responsibilities

• Translates the project strategy into an achievable quality plan covering all department activities, including risk management, process validation, and control strategies from raw materials to commercial product. You align the Platform/Segment with this strategic direction.
• Determine how to best apply allocated means/resources to meet objectives.
• Lead the execution of the quality plan to ensure project success: Understand the targeted market impact to define customer requirements and applicable quality standards.
• Ensure Design Control activities are properly followed.
• Lead product risk management activities.
• Initiate change requests and define the quality response in close collaboration with R&D and Engineering.
• Ensure that a product and process design validation plan is established and that manufacturing process validation activities are accomplished “right the first time.”
• Ensure supplier qualification strategies and plans are defined and completed.
• Ensure the robustness of test methods used in project activities is appropriate for the intended use of the results.
• Define or update the product and process control strategy by integrating past findings and operational strategies.
• Approve the release of products under development.
• Ensure quality oversight of project management, including design definition, data synthesis, interpretation, and associated documentation.
• Identify issues that could impact the product or project and recommend appropriate actions.
• Lead quality reviews at key project achievements and at project closure.
• Contribute to the management of investigations and problem resolution in case of deviations from product requirements.
• Develop solutions to resolve complex problems, often requiring ingenuity and creativity.
• Review and approve changes to product and process specifications, test method validations, etc., on behalf of Quality Engineering.

Preferred Requirements

• Deep understanding of ISO 13485, QSR, and GMP regulations. Strong command of Design Control principles and advanced knowledge of statistical quality assurance methods and Six Sigma methodology.
• Confirmed experience in quality systems, validation, FMEA, and risk management. Solid understanding of manufacturing processes and their quality implications.
• Able to independently lead multiple projects from design initiation to implementation and maintenance.
• Excellent written and verbal communication skills, including fluency in English.
• Demonstrates ownership and accountability for project success.
• Adaptable and committed in the face of change and uncertainty. Aligned with BD’s values and quality culture. Strong understanding of the healthcare industry and related technologies.

Salary range for the role: €55,000 to €65,000

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.