Worldwide Quality Engineer

BD; Le Pont-de-Claix; Sur place; EUR 55 000 - 65 000; Plein temps

Résumé du poste

A leading medical technology company in Auvergne-Rhône-Alpes is seeking a Quality Engineer. This role requires expertise in quality assurance and project management, ensuring that products meet regulatory requirements. The ideal candidate will have a strong background in ISO standards and the ability to lead multiple projects effectively. The position offers a salary range of €55,000 to €65,000 and emphasizes on-site collaboration.

Qualifications

• Deep understanding of ISO 13485, QSR, and GMP regulations.
• Experience in quality systems, validation, FMEA, and risk management.
• Able to independently lead multiple projects.

Responsabilités

• Translate project strategy into a quality plan covering all department activities.
• Lead the execution of the quality plan to ensure project success.
• Ensure Design Control activities are properly followed.

Connaissances

ISO 13485 knowledge

Design Control principles

Statistical quality assurance methods

Six Sigma methodology

Risk management

Excellent communication skills

Adaptability

Description du poste

Overview

Worldwide Quality Engineer role at BD. 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 (e.g., Plant, Validation, Sterilization, Supplier). You combine design control expertise, problem-solving approaches and analytical skills to support projects/complex activities using strong quality engineering skills including risk management, process validation and control strategies. This position will play an active role in ensuring products meet customer/patient needs and quality standards consistently with corporate and unit policies, while meeting all design control and other regulatory applicable requirements.

Responsibilities

• As the Quality Representative within the Project/Program Team: 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. 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.
• 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.
• 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

About BD

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and it takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our MedTech products—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are passionate and committed to fostering an inclusive, growth-centered culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture and understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

At BD, on-site collaboration is prioritized to foster creativity, innovation, and problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days in-office per week is expected to maintain our culture of excellence; flexible arrangements or remote work will be indicated in the job posting.

Equal Opportunity

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.

To learn more about BD visit: https://bd.com/careers

Primary Work Location

Salary or hourly rate ranges are provided to reward associates fairly and competitively, and depend on location, experience, and other factors. Details available on our Careers Site under Our Commitment to You.

The salary or hourly rate offered to a successful candidate is determined by experience, education, and skills, and by applicable labor laws and agreements.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Medical Equipment Manufacturing