Quality Associate

Join Baxter Healthcare Corporation as a Quality Associate in Engineering, contributing to top-tier product quality and safety, in Braine L'Alleud.

As a Quality Associate, you will be instrumental in ensuring the successful completion of new and improved product design and implementation projects. Your expertise will play a vital role in maintaining flawless quality standards while adhering to project timelines and budgets.

Whatyou'll do :

• 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, participating as an auditor in internal audits and follow-up activities.

• Provide mentorship on maintaining product Design History Files and Risk Management Files in accordance with relevant Quality System and other regulatory requirements for therapeutics and medical devices.

• Collaborate with Research & Development, Regulatory Affairs, Manufacturing, and other collaborators to represent the quality function in project teams, ensuring that project quality objectives are met.

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

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

Whatyou'llbring

• Educational Background: A Bachelor’s degree in a relevant field such as Quality Assurance,Pharmacy, Life Sciences, 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, FDA 21 CFR, and Good Manufacturing Practices (GMP).

• Quality Systems Expertise: Proven experience in implementing and maintaining quality 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 and maintaining quality 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 high importance 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 reasonable accommodation to applicants with disabilities. If you require reasonable accommodation 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, strictly maintaining our standards of excellence!

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