Quality Associate II - Onsite Weekdays

About Baxter

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 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.

Important:
This position is located in Medina, NY and is designed as an onsite role, with an encouraged presence of five (4) days per week to foster collaboration, innovation, and connection across the team. Baxter is seeking candidates who reside within a reasonable commuting distance and are able to regularly support the business through in-person engagement and partnership at the Medina site.

• 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 (21
  
  CFR 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.
• 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).
• Assist other quality areas in the successful performance of these activities when required.
• 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…