Quality Associate

Jobinhalt

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.
Join Baxter Healthcare Corporation as a QualityAssociate in Engineering, contributing to top-tier product quality and safety, in BraineL’Alleud.

As a Quality Associate, you will be instrumental in ensuring the successful completion of new and improved product design and implementation projects. Yourexpertisewill play a vital role inmaintainingflawless quality standards while adhering to project timelines and budgets.
Whatyou’lldo :

• Implement Quality System processes on site for new product development and lifecycle management.
  

• Review documentation for accuracy and compliance, decide on release or rejection, focusing on Design & Development, stability studies, and analytical methods.
  

• Demonstrate compliance of development processes and change management during internal and external audits and inspections,participatingas an auditor in internal audits and follow-up activities.
  

• Provide mentorship onmaintainingproduct Design History Files and Risk Management Filesin accordance withrelevant Quality System and other regulatory requirements for therapeutics and medical devices.
  

• Collaborate with Research & Development, Regulatory Affairs, Manufacturing, and other collaborators torepresentthe quality function in project teams, ensuring that project qualityobjectivesare met.
  

• Act as a quality approver for design and quality system change controls.
  

• Participate in and approve NCR/CAPA records, supporting the investigation andappropriate resolution.
  
  

Whatyou’llbring

• Educational Background: ABachelor’sdegree in a relevant field such as Quality Assurance,Pharmacy, LifeSciences, Engineering, or a related subject area.
  

• Experience: A minimum of 5 years of experience in quality assurance or quality control within the pharmaceutical, biotechnology, or medical device industries. Familiarity with product design and implementation processes is highly desirable.
  

• Regulatory Knowledge: Strong understanding of regulatory requirements and quality standards applicable to drugs and medical devices, including ISO 13485, FDA21 CFR, and Good Manufacturing Practices (GMP).
  

• Quality Systems Expertise: Proven experience in implementing andmaintainingquality management systems, particularly in a research and development environment.
  

• Analytical Skills: Outstanding analytical and problem-solving skills, with the ability to assess complex situations and develop effective solutions.
  

• Attention to Detail: A meticulous approach to work, ensuring that all quality processes are followed accurately and thoroughly.
  

• Communication Skills: Strong verbal and written communication skills, with the ability to effectively collaborate with cross-functional teams and convey complex information clearly.
  

• Project Management: Experience in managing multiple projects simultaneously, with a focus on meeting deadlines andmaintainingquality standards.
  

• Approach for Continuous Improvement: A proactive attitude towards continuous improvement, with a willingness to learn and adapt to new quality practices and technologies.
  

• Technical Proficiency: Familiarity with quality management software and tools, as well as proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
  
  

What are some of the benefits of working at Baxter Healthcare Corporation?

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

Equal Opportunity Employer Statement: Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Reasonable Accommodation Statement: Baxter Healthcare Corporation is committed to providing reasonableaccommodationto applicants with disabilities. If you requirereasonableaccommodation during the application process, please let us know.

Join us in this ambitious role where your contributions will help us compete at a world-class level, strictlymaintainingour standards of excellence!




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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