Demo

Quality Assurance Associate

Baxter
Medina, NY Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/9/2025

Your Opportunity to Make a Difference at Baxter

At Baxter, we are united by our mission to save and sustain lives. Every role plays a crucial part in enhancing patient outcomes across the globe. You will experience a profound sense of purpose as your work contributes positively to millions of patients’ lives.

For over 85 years, Baxter has been at the forefront of medical innovation, providing products and therapies found in hospitals, clinics, and homes worldwide. We take great pride in fostering a workplace where creativity thrives, success is a collective endeavor, and inspiration abounds. Join us and become a vital part of a team that truly makes a difference.

Your Role at Baxter

As a Quality Assurance Associate, you are a proactive problem-solver who embraces challenges. Your creativity will allow you to navigate complex processes while ensuring the utmost quality in the products you support. You excel at absorbing detailed information and sharing knowledge across your team. Your commitment to safety and quality drives you to complete tasks efficiently and effectively.

Why You Will Love Being a Part of Our Team

Your contributions in Quality are essential to our operations. Each product plays a role in enhancing the lives of patients globally. You will be entrusted with the opportunity to innovate and tackle new challenges head-on, ensuring excellence from the ground up.

You will foster relationships built on reliability, transparency, and mutual respect. Our team thrives on collaboration and accountability, making it easy to share insights and drive improvements. Together, we prioritize quality in every decision we make.

Key Responsibilities

  • Manage and approve various Quality System Records.
  • Conduct root cause investigations for nonconformances and implement effective corrective actions.
  • Identify and implement process improvements to enhance product and process quality continuously.
  • Mentor team members in developing investigation plans and outcomes.
  • Ensure prompt completion of Quality System activities.
  • Verify the completeness of Quality System records across relevant functions.
  • Compile and present findings to both internal and external CAPA Review Boards.
  • Develop and deliver training as needed to uphold quality standards.
  • Generate weekly reports on nonconformances as necessary.
  • Participate in audit readiness and support various types of audits.
  • Review Global Observations and Quality Alerts according to established standards.
  • Assist in Change Control Management as a Quality Assessor.

What You Bring to the Team

  • Bachelor's degree in a science-related field.
  • 2 years of experience in quality assurance within a regulated industry, preferably medical devices or pharmaceuticals.
  • Familiarity with Quality Systems, 21 CFR Part 820, ISO 13485, and related standards.
  • Strong understanding of risk management, root cause analysis, and corrective actions.
  • Experience utilizing statistical tools for quality analysis.
  • Ability to create procedures addressing corrections and corrective actions.
  • Proficient in Microsoft Office and database management; familiarity with Trackwise is advantageous.
  • Excellent interpersonal and communication skills, with strong project management abilities.
  • Attention to detail and capacity to manage multiple priorities under pressure.
  • A genuine understanding of FDA regulations and relevant practices.
  • Physical Demands

    The role involves standing, sitting, and walking throughout the day, with reasonable accommodations available for individuals with disabilities.

    Work Environment

    This position is based in a manufacturing setting subject to FDA regulations. Employees are expected to adhere to safety protocols, including wearing a static protective smock and collaborating closely with others.

    The Medina Plant will be the primary location for this role.

    Competitive Compensation and Benefits

    We value your talent and offer a comprehensive compensation package, including health, dental, and retirement benefits with a 401(k) plan and Employee Stock Purchase Plans. You’ll also enjoy generous paid time off, family leave, and additional benefits designed to support your well-being.

    Equal Opportunity Employer

    Baxter is an equal opportunity employer and evaluates applicants based on qualifications without regard to race, gender, sexual orientation, or other protected characteristics.

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