Quality Assurance Specialist

Zvh; San Vittore; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Baxter is seeking a Quality Assurance Specialist to ensure plant activities comply with GMP and quality policies, leading investigations and driving corrective actions across cross-functional teams.

You will support supplier qualification, audits, and training, while maintaining electronic quality documentation and ensuring readiness for inspections. Strong collaboration and a proactive approach are essential in this role.

Qualifikationen

• Experience with Quality Management Systems (QMS) and GMP/ISO 13485.
• Proven ability to lead investigations and corrective actions.
• Strong safety awareness and adherence to internal procedures.
• Excellent communication and cross-team collaboration.

Aufgaben

• Be responsible for quality records creation, review, distribution and archiving per Good Documentation Practices.
• Lead non-conformity investigations and CAPA plans, identify root causes and implement sustainable solutions.
• Drive supplier qualification and supplier quality activities to meet Baxter standards.
• Support internal and external audits and readiness for inspections.
• Provide training and coaching across areas to maintain high compliance standards.
• Review and update quality policies, procedures and Quality Manual to align with requirements.
• Manage electronic quality documentation to keep records accurate and accessible.
• Partner with departments to keep processes current and effective.
• Promote a culture of continuous improvement and process efficiency.

Kenntnisse

QMS & GMP

ISO 13485

CAPA investigations

Investigations management

Cross-functional collaboration

English & Italian

Ausbildung

Engineering or Scientific degree

Jobbeschreibung

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.

About the role

As a Quality Assurance Specialist, you will play a key role in ensuring that our plant activities are carried out in line with GMP requirements and company quality policies. Working closely with cross-functional teams, you will lead quality investigations, drive corrective actions and training, support supplier qualification activities, and help ensure our site remains aligned with regulatory and quality requirements. This is an excellent opportunity for someone who enjoys solving problems, collaborating across departments, and influencing positive change.

What you will be doing

• Be responsible for the functional activities associated with the creation, review, distribution and archiving of quality records in accordance with Good Documentation Practices guidelines.
• Lead non-conformity investigations and corrective action plans, identifying root causes and implementing sustainable solutions to prevent recurrence and strengthen product quality.
• Drive supplier qualification and supplier quality activities, ensuring suppliers meet Baxter's quality expectations.
• Support internal and external audits, helping ensure ongoing compliance and readiness for inspections.
• Provides training and coaching in their respective areas of expertise, helping employees understand their responsibilities and maintain high compliance standards.
• Review and update quality policies, procedures, and the Quality Manual, keeping the Quality Management System aligned with Business requirements.
• Manage electronic quality documentation processes, ensuring records are accurate, controlled, and accessible to support compliance and operational efficiency.
• Partner with departments across the site to keep processes current and effective, ensuring procedures reflect standards and regulatory expectations.
• Promote a culture of continuous improvement, finding opportunities to enhance processes, increase efficiency, and strengthen overall quality performance.

What you will bring

• Experience working with Quality Management Systems, ideally within the pharmaceutical, medical device industries and solid understanding of Good Manufacturing Practices (GMP) and/or ISO 13485 requirements.
• Degree in Engineering or Scientific field preferred, or equivalent experience considered.
• Proven experience managing investigations, corrective actions.
• Ability to operate in compliance with safety standards and internal Quality procedures.
• Strong communication and collaboration skills, with the ability to work effectively across different teams.
• A proactive approach with strong problem-solving capabilities.
• Good level of English and Italian.

Why You Want to Work at Baxter

Competitive salary according to experience. Purposeful work where your contribution directly supports healthcare professionals and patients. A collaborative and supportive culture that values teamwork and continuous improvement. Career development opportunities within a global healthcare leader operating in more than 100 countries. Lead meaningful projects and drive improvements throughout the site. Be part of a global organization with a strong commitment to innovation, integrity, and professional development.

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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.