This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Summary:
As a Quality System Leader: develop, maintain and manage the R&D Site(s) Quality Management System to ensure compliance with the requirements of the customers, of the Health Authorities and the Corporation.
Essential Duties and Responsibilities:
- Ensure site compliance to applicable regulations and standards and maintain site certifications.
- Ensure Quality System processes are correctly implemented on site.
- Recommend, lead, and/or support projects for improvements to the quality system.
- Identify Key Quality Indicators to provide data for continuous improvement and potential escalation.
- Ensure site audit readiness for internal, external, and unannounced audits - Drive success in audits, compiling audit responses and tracking audit commitments.
- Support Supplier Quality responsibility for the R&D site, and participate in supplier audit, as needed.
- Implement and participate as auditor to the internal site audit program.
- Manage, identify, hire, develop and recognize the Quality System team.
- Ensure appropriate documentation is complete, correct, that the schedules of any reviews are met.
Qualifications:
- Demonstrates leadership skills and ability to work independently.
- Working knowledge of ISO 13485:2016.
- Problem Solving – Apply DMAIC and statistical techniques to address issues and investigations.
- Resourceful and independent - Applies organizational and technical knowledge to move teams through issues.
- Recognized as a Quality System expert by peers and other design site personnel.
Education and/or Experience
- Degree in Engineering (or equivalent) and 8-10 years of experience in the area of Medical Device Quality and/or Regulatory.
- 5+ years team manager experience.
- Demonstrated success in delivering results.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €44,800.00.00 annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.
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.
