Quality Systems Associate

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.

Your Role at Baxter

This role supports the Quality Systems Manager on meeting key deliverables. This position is responsible for supporting and/or owning the systems owned by Quality Systems: Training, Document Control, Change Control, Management Review and Quality Audits. Requires a solid understanding of medical device regulations as it relates to these systems. It is expected to manage multiple projects and must be able to work with and support groups at all levels. The position requires interaction with corporate, other Baxter sites and constant collaboration with site departments including but not limited to: Product/Process development teams, QC, Manufacturing, Quality Operations.

What you'll be doing

• Develop and sustain the Quality Management System in line with the required regulatory, industry standards (ISO 13485) and business needs.

• Implements, maintains and administrates Quality Systems procedures, standards and systems.

• Document Control - controlled forms, periodic review

• Training - management of system, improvements, compliance

• Compliance - internal & external audits, site certifications, global & regulatory compliance, field actions

• Management Review - compilation of slides, drive action items and presentation of content

• Change Control - assessments, approval, management

• Support Quality Manager in maintaining metrics for Quality System and prepare slides accordingly for respective meetings. Identify trends and improvements.

• Knowledgeable of the QMS KPIs for management review meetings and other platforms as needed.

• Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

• Lead site training for Quality Systems; coach and mentor individuals and teams by maintaining a high level of expertise in current regulatory requirements.

• Initiate and/or own nonconformance reports and support investigations as needed.

• Perform internal audits. Coordinate, host and respond to internal & external audits. Train/prepare site staff for audits.

• Support global initiatives for site improvements (Prosite Model, GOC) working cross-functionally to address issues and implement improvements.

• Participate in multi-site Quality projects in the role of contributor, coordinator, or lead.

• Other duties, tasks or projects as assigned.

What you'll bring

• Bachelor's degree in science or engineering

• Minimum of 5+ years of experience in Quality with emphasis on regulation and compliance, or related field in the medical device industry.

• Must be experienced with interpreting quality system regulations.

• Audit experience (as auditee or auditor) is required.

• CQA, ISO 13485 Auditor certifications are a plus.

• Team Player with strong interpersonal/management skills

• Excellent problem-solving skills, attention to detail, verbal and written communication

• Good project management skills

• Working knowledge of FDA/ISO Regulations (ISO 13485, 21 CFR 820 Quality Management System regulations), Application of Good Documentation Practices and Application of Good Manufacturing Practices

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 estimated base salary for this position is $88,000 - $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. 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.

#LI-KV1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

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.

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