Mgr I, Quality Assurance

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. Your role at Baxter: You as, Mgr I, Quality Assurance, will be responsible for overseeing Quality Assurance activities that ensure products, processes, and systems align with GMP, ISO standards, corporate policies, and regulatory requirements. This role leads QA teams, handles quality system elements, reviews and approves critical documentation, supports audits, and partners closely with multi-functional teams to ensure consistent product quality and operational perfection. The position also drives continuous improvement initiatives while maintaining an audit‑ready quality culture throughout the organization. What you will be doing: Lead all aspects of running resources and organizing activities related to product inspection and compliance with DMR Assures a robust identification and quality status process is in place, responsible for quarantine areas and local product retention process. Develop and evaluate Quality Sampling Plans techniques for further improvement. Supports the implementation process control activities. Participate and maintain full knowledge of the Operations / Management Review/ Quality Project Review. Assure quarterly Quality System Management reviews are to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvement process. Assure test method instructions are met during the inspection process. Assure raw material and Finished Goods Release in compliance with product specifications. Develop and assign resources to assure Product Release in accordance with Corporate Objectives. Lead resources and coordinate tasks associated with Complaints and NCR investigations. Participates and provides feedback for process, product, equipment and software validation activities and be facilitator of long-term Quality Programs. Assure Incoming area compliance with corporate and local procedures and create VIP and improvement plans related to Incoming area. Lead engineering resources to set workload priorities in areas of responsibilities as established by Management. Initiates or recommends special studies and analyses of new products or processes to evaluate quality and reliability. Responsible for conducting Complaints Review Monthly Meeting and assign improvement actions. Evaluates and assures product’s quality through quality indicators and keeps product release performance within standards. Provides Software Validation support as the need arises. Develops and leads VIP objectives and monitors implementation results. Coordinates and evaluates new projects with pertinent plant personnel. Monitor and approves all manufacturing and quality Standard Operating Procedures and compliance. Controls SPC, Six Sigma and CPK concepts until its final implementation. Revises specifications and recommend changes. Veil for clean room compliance with GMP, FDA, ISO and other Regulatory Agency requirements. Supports the evaluation of customer complaints and implementation of Corrective and preventive Actions. Leads Non-conformance Investigations (NCR, CAPA, etc.). Assures linkage of these systems with defect monitoring process. Meets with manufacturing, MIS, Process/Product and Automation Engineering to assist in the implementation/evaluation of new or improved processes and equipment. Supports on FDA and Third-Party inspections. Observes all interpersonal and legal EHS requirements. Identify hazards and evaluate potential dangers along with environmental aspects of areas and processes under responsibility and implement appropriate control. Learn and apply fundamental ergonomic concepts to reduce job-related discomfort and injuries. Identify and evaluate every hazard and ecological factor within the area of responsibility. Able to recognize new risks. Ensure that personnel under their supervision are trained and understand the hazards as well as the natural and ecological aspects of the area. Lead and Deploy ICare segment: BBQ (Behavior Based on Quality) in alignment with Site strategy. Align with all company and regulatory Environmental, Health, and Safety (EHS) requirements. Apply ergonomic principles to minimize job related discomfort and reduce the risk of injury. Maintain awareness of all risks and environmental aspects associated with the work area and actively support the identification and reporting of new risks. What will you bring? B.S. or equivalent experience in science, Pharmacy, Industrial Engineering, or a related field. Fully bilingual (English & Spanish). degrees may be considered if it is commensurate with significant quality assurance experience in a medical industry Devices or regulated industry. At least seven years working in Quality, including at least one year serving in supervisory positions. American Society for Quality (ASQ) Certified Quality Engineer (CQE) – preferred. Green Belt Six Sigma, Internal/Lead Auditor – preferred Computer System, Window Microsoft– Office (Word, Excel, presentation software), 21 CFR Part 11, OSHA, GMP, General FDA Regulations, Good Documentation Practices, CAPA, Internal Audit, Training knowledge and application. 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 par