Senior Quality Specialist

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.

Role Summary:

• Reporting to the Manager, Quality Assurance – Singapore, this role will support the development, implementation and maintenance of facility quality systems ensuring compliance to existing Quality System for Singapore Operations
• The primary focus is to define appropriate QMS standards/procedures and to assess appropriate compliance with them and, where necessary, to organize support in achieving compliance with all applicable local Asian and medical device regulations such as Good Distribution Practice in Singapore. This role will have to demonstrate the ability to complete and/or manage site remediation activities to achieve compliance with corporate and regulatory agency requirements. Another key focus is to ensure site is well prepared for external audits by notified bodies/ certification bodies or competent authorities
• This role will drive Corrective Action and Preventive Action (CAPA), internal audit program, support second-party and third-party audit for Singapore Operations. Be responsible for data mining and analysis and provide trending analysis result of overall health status of Quality Management System

Essential Duties & Responsiblities:

• Functional Lead for implementation, maintenance of CAPA Activities, host CRB
• Functional Lead for implementation, maintenance of trending activities, host local trending meeting
• Consolidate and analyze data associated with defined KPIs or Scorecard
• Study any unfavourable trending and take appropriate action via CAPA system to identify root causes, rectify the issues and develop sustainable solutions
• Be a key contributor to the Quality Management System activities for Singapore Operations
• Play an active role in Internal Audits and External Audits
• In partnership with Manager, QA, define measurable key metrics, establish controls, lead implementation of control to ensure satisfactory completion for QMS
• Take full ownership of maintaining, reviewing and updating Interface Agreement Log periodically
• Enable rapid and effective correction of quality/regulatory problems in a manner that prevent their recurrence
• Participate in special projects and initiatives as required

Education & Experience:

• Bachelor’s Degree in Engineering, Science, or related discipline
• Must have previous experience in a medical device engineering or manufacturing environment.
• Proficient in the use of standard quality engineering tools
• Experience in a growth-oriented, multi-national R&D, manufacturing and sales organization
• At least 6 years’ experience working in a multi-national company in a similar position or position of responsibility in the quality field
• A certified lead auditor for ISO13485:2016/ MDSAP
• Strong knowledge of quality system requirements, namely FDA 21CFR Part 820 Quality System Regulation, European Medical Device Directive (MDD), European Medical Regulation (MDR) and ISO13485 Quality System Standards. Demonstrate ability to drive change within organization; strong communication skills and ability to deal with important issues
• Possess strong knowledge of CAPA and root cause analysis
• The work environment is a changing environment, where a need to adapt to change easily, show flexibility, prioritization, organization and time management skills are a pre-requisite
• Able to work in both a collaborative (team) environment as well as perform independent work as required
• Excellent interpersonal, influencing and presentation skills
• Record of positive interactions with medical device regulators, notified bodies and standards-setting bodies
• Ability to understand your audience and tailor information/communication to be effective
• Collaborate effectively across a diverse network to learn and improve for best-in-class regulatory performance. · Computer competency in Word, Excel, PowerPoint, Agile, and SAP
• Fluent English is essential for this role

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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