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.

The Compliance & Records Management, QAII is responsible for site QA Compliance, Internal/External Audits, Site Audit Readiness and all aspects of hosting Audits, Regulatory Intelligence (GOC), Management of the Global Entity review and Periodic Review processes, QA site Model, and other Quality System items as assigned. Main responsibilities include ensuring compliance with Regulations and corporate processes. Additional responsibilities related to Records Management include serving as the Site Records Management Coordinator and Subject Matter Expert.

• This position's primary responsibility is ensuring compliance with Regulations and corporate processes such that desired business results are achieved.
• Develop and sustain the Quality Management System in line with the required regulatory and industry standards (ISO 13485) and business requirements.
• Understand and ensure conformance to regulations per FDA Quality System Regulation (21CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations SOR/98-282, as well as Baxter Global Policies and Procedures applicable to elements of the Quality System.
• Manage site certifications, external registration requirements. Liaise with external bodies on matters relating to registration.
• Manage various aspects of the audit lifecycle including planning, scheduling, notification, executing, hosting, issuing reports, evaluating responses, requesting clarifications, issuing and closing CA/PA's. This may include qualification of Site internal auditors.
• Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Serve as Subject Matter Expert (SME) in Quality compliance by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other quality areas in the successful performance of these activities.
• Lead Audit Readiness efforts for the site and ensures compliance to regulatory requirements.
• Manage the site Internal Audit Program, participate in audits and/or qualify/oversee alternate Site auditors, plans for corrective and preventive actions related to internal audit findings or gaps identified in the QMS.
• Manage Site Compliance programs such as Global Observation Certification, Global Entity Review, and Periodic Review
• Strategize quality improvement activities in collaboration with other departments.
• Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner.
• Provide detail analysis of the QMS critical metrics for management review meetings and other platforms as needed.
• Balance cost, quality, people, and delivery objectives to meet plant goals using standard enterprise management system.
• Ensures critical metrics are met by working to overall plan, including management of, and reporting.
• Support in failure investigation activities (CAPA projects) to identify the root cause, develop appropriate corrective/preventive actions and approve CAPA's, NCR's.
• Maintain an inventory of stored Records
• Ensure Records are indexed and tracked for ease in retrieval.
• Ensure Records are archived/stored in appropriate locations (both electronic and physical).
• Track storage submissions and retrieval activities for records submitted to and/or stored with offsite storage providers.
• Monitor/adhere to Legal Hold Orders
• Annually evaluate Records to determine their destruction eligibility.
• Periodically (at least annually) review trigger dates to enter known dates that have occurred.
• Prepare and route destruction eligibility reports/lists for review by Functional Leaders
• Upon approval, destroy Records in a timely fashion in compliance with Baxter's policies and procedures.
• Other duties, tasks or projects as assigned.

• Bachelor's degree in a science/math related field is required. Masters' degree preferred.
• Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field with a medical device/pharmaceutical company or similar regulated industry, preferred.
• Must be experienced with interpreting quality system regulations. Audit experience is preferred.
• Working knowledge of Quality Systems and related requirements and standards, including 21 CFR
• Part 820, ISO 13485, preferred.
• Knowledge of risk management, root cause analysis, corrective and preventive action and document control.
• Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.
• Proficient with computers and in the use of Microsoft Office Suite.
• Strong verbal / written communication skills, problem solving and personal conflict resolution skills.
• Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision.
• Project management skills and must be able to handle multiple projects concurrently.
• Ability to communicate with all levels within the organization.
• Able to demonstrate responsiveness to customer needs, within job scope.
• Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices.
• Comprehension of design methodology, product configuration and complex manufacturing processes.
• Ability to excel in a team-oriented environment.

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 our employees, and we strive to be more transparent with our pay practices.To that end, this position has a salary range of $76,000-$104,500 and also includes an annual incentive bonus. The above range represents the expected salary range for this position.The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

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

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