This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

The Design Quality Manager collaborates with project teams in New Product Development at our Pluvigner, France site.

Develop and implement top-notch Design Controls procedures for safe products and quick market entry. Engage in Design Assurance projects to boost new product quality and regulatory compliance.

What you will do:

• Ensure Design Control elements align with Quality System on NPD teams.

• Prepare and/or approve QA/RA required NPD deliverables and support the team in developing a quality product that meets regulatory requirements.

• Ensure product development activities related to verification and validation are fully aligned with quality system procedures.

• Facilitate and complete root cause analysis investigations when design challenges are encountered.

• Work with the project leader, systems engineers, and design engineers to plan and conduct robust design reviews.

• Ensure critical design characteristics are identified for the accurate level of controls.

• Actively participate and assist teams with developing the Risk Management File, including Risk Assessments, SFMEA, DFMEA/PFMEA, FTA, etc.

• Facilitate and support various reviews throughout the project, including Phased Gate Design Reviews and Post Launch Analysis.

• Actively participate in or lead Design History File audits and follow-on remediation efforts as required.

• Actively participate in and support internal and external audits/inspections.

• Actively participate in or lead CE marking and support international registration.

• Own or participate in the completion of CAPAs.

• Participate in various continuous improvement/process improvement teams.

• Develop, modify, or review for approval any procedure related to product development.

• Understand the impact of your activity or behavior on safety, the environment, and energy performance.

• Align with established rules on safety, environmental protection, and reducing energy consumption, and be aware of the repercussions of non-compliance.

• Take responsibility for your own contribution to achieving safety, environmental, and energy performance objectives.

• Immediately report risks and risky behavior that could impact safety, the environment, and energy performance.

What you will bring:

• Strong, demonstrated ability to interact closely on technical terms with R&D personnel is required.

• Diligent with strong organizational and record-keeping skills is required.

• Strong problem-solving and root cause analysis skills are preferred.

• Strong written and oral communication skills using the English language are required; ability to describe complex issues succinctly and clearly in meaningful ways is required.

• Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts is required.

• Demonstrated ability to be proactive and timely in the execution of assigned tasks is required.

• Ability to be flexible and adaptable to changing priorities is required.

Education and/or Experience:

• Bachelor’s Degree in engineering or related field or equivalent experience is required.

• Prefer 0 - 2 years in regulated technical industry like aerospace, automotive, or defense.

What are some of the benefits of working at Baxter?

We offer a driven total compensation package, with professional development opportunities, where a high importance is placed on work-life balance.

Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Reasonable Accommodation Statement: Baxter Healthcare Corporation is committed to providing reasonable accommodations to applicants with disabilities. If you require a reasonable accommodation during the application process, please let us know.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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