Quality Manager at Baxter… · Cartago

Quality Manager Location: Cartago, Cartago 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 Quality Manager are responsible for leading quality control efforts within the facility. These efforts support manufacturing operations and ensure compliance with medical device, pharmaceutical, combination-product, and solutions regulations. This role serves as the main QA representative on the shop floor. It offers real-time quality oversight, decision-making, and works with Operations to ensure product quality, safeguarding patients, and regulatory compliance. The role has accountability for quality assurance activities on the production floor, batch review and release, nonconformance management, investigations, CAPA execution, and complaint handling, and acts as a key Quality interface for site leadership and regulatory inspections. What you will be doing: Provide a strong QA presence on the manufacturing floor. Ensure manufacturing activities follow approved procedures, batch records, and applicable legal and industry standards for solutions, medical devices, or pharmaceutical products. Support real-time quality decision-making during manufacturing, including line clearances, process adherence, identification of deviations, and resolution of quality issues. Act as the primary Quality partner concern point for shop-floor issues that may impact product quality, compliance, or patient safety. Own or supervise batch record review, disposition, and product release activities, ensuring documentation is complete, accurate, and compliant prior to release. Make independent, risk-based batch release decisions in alignment with quality standards, site procedures, and regulatory expectations. Ensure timely batch release while balancing supply continuity and compliance requirements and support interactions with QP or responsible release functions where applicable. Lead and handle nonconformances, deviations, and quality events, ensuring issues are accurately detailed, investigated, and closed within defined timelines. Drive high-quality root cause analysis and ensure corrective and preventive actions are appropriate, effective, and balanced. Ensure CAPAs address systemic issues and actively supervise efficiency to prevent recurrence. Lead or offer QA supervision of manufacturing and quality investigations, ensuring investigations are scientifically sound, risk-based, and meet regulatory expectations. Review and approve investigation documentation, impact assessments, conclusions, and links to batch disposition and CAPAs. Ensure investigation outcomes are clearly supported, traceable, and inspection ready. Deliver QA oversight for product complaints, including complaint evaluation, investigation, trending, and regulatory impact assessment as applicable. Ensure complaints are assessed regarding their effect on product quality and patient risk, and that documentation meets internal and regulatory requirements. Partner with Regulatory Affairs and site team members to support timely complaint responses and reporting obligations where required. Support and actively participate in regulatory inspections, internal audits, and customer audits at the site. Ensure manufacturing-related quality documentation, including batch records, deviations, investigations, CAPAs, and complaints, is inspection ready. Give to responses to audit findings and ensure sustained remediation of identified issues. Act as a crucial Quality partner to Manufacturing, Operations, Engineering, Supply Chain, and Site Leadership. Provide coaching, mentorship, and training to manufacturing teams on Quality expectations, compliance requirements, and right-first-time behaviors. Promote a strong culture of quality ownership, accountability, and continuous improvement while operating in a fast-paced, regulated manufacturing environment. Call out quality and compliance risks appropriately to site and Quality leadership. What will you bring? Bachelor’s degree experience in science, Engineering, or equivalent 5–8+ years of Quality Assurance experience in regulated manufacturing environments (medical devices, pharmaceuticals, or solutions) Hands-on experience with QA on the floor, batch release, deviations, investigations, CAPA, and complaints Strong understanding of applicable quality systems and legal standards Experience supporting audits and compliance reviews Preferred Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, or combination products Prior site-level Quality leadership experience in manufacturing environments Exposure to continuous improvement or operational quality initiatives 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.