Quality Associate M/w
il y a 19 heures
**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**
Working for Baxter is all about saving and sustaining lives. As our product quality associate you get to contribute to our mission by ensuring quality is inherent by design. Our dedication to quality has allowed us to become a leader in industry. We offer a full-time employment contract with incredible development opportunities.
We offer a fantastic opportunity to work in a passionate team and dynamic environment.
**Essential Duties and Responsibilities**:
As a QA associate, you’ll demonstrate your quality expertise across various projects. You’ll be required to work and interact with other teams and departments, in order to ensure the necessary quality of products and processes. More specifically, you will:
- Ensure compliance of Baxter procedures with the relevant standards and update procedures when needed.
- Provide quality insight, assessment and approval to product and process changes to ensure compliance and keep safe and effective Drugs and Medical Devices on the market.
- Provide support for New Product Development and guide teams through the development process to ensure compliance to quality systems
- Utilize DMAIC tools to promote structured non-conformance investigation and participate in corrective and preventive actions (CAPA) related activities.
- With mínimal guidance, lead a team through the quality planning and execution of projects
- Support Quality internal and external audits. Serve as an internal auditor if required.
**Qualifications**:
- Extremely well organized and paying meticulous attention to details.
- Knowledge of quality assurance terminology, methods, and tools
- Technical skills on Drug and Medical Devices regulations during New Product Development and Life Cycle Management projects, Change Control and Risk management processes.
- Analytical, problem-solving, and decision-making skills- Knowledge of statistical tools and techniques.
- Fluent speaker in English
- French nice to have
**Education and/or Experience**:
- Scientific University degree (Engineering, chemistry, biochemistry...)
- Qualified Person (QP) qualification is an asset
- Knowledge of FDA (21 CFR Part 210 & 211), ICH, and EMEA regulations (EU GMP Part I & II), ISO13485 and ISO14971, MDSAP.
- 2-to-3-years’ experience in the Pharmaceutical/ Medical Device environment
- Experience in leading project and Quality Initiatives in an international environment.
Join us to save and sustain lives.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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