Job Description

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\xe2\x80\x99ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter\xe2\x80\x99s 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\xe2\x80\x94 where your purpose accelerates our mission.

What you\'ll be doing

• Assigns and manages the work of self and direct reports to:
• Develop and implement systems, procedures, and policies to assure compliance with appropriate regulatory agencies and regulations to include but not limited to ISO Standards, cGMP\'s, FDA regulations and company policies and procedures.
• Author, review and implement the quality systems procedures in several sections or departments and manages compliance to the system.
• Drives quality and manufacturing improvements to ensure our processes are in state of control.
• Assure product compliance to specifications through implementation of inspection criteria and procedures in operation\xe2\x80\x99s processes.
• Manage interactions with regulators and customers to represent the company products and processes.
• Develop and analyze statistical data and product specifications to determine present standards and establish proposed finished product\xe2\x80\x99s quality and reliability expectancy.
• Apply standard operating practices and problem-solving methodology across the organization. Serve as role model and coach to employees at all levels in the application of best practices.
• Identify and lead projects and initiatives to improve the quality system. Interact with Baxter larger organization on projects and initiatives as assigned.
• Manage and develop staff.
• Financial responsibilities and accountabilities include department and capital budgeting and expenditures for areas of responsibility.
• Understands and assures conformance to regulations applicable to several sections or departments. Interfaces with regulators during inspections.
• Serve as deputy Site Management Representative, as needed.

What you\'ll bring

• BS in science or engineering; advanced degree helpful.
• 5 years of experience in Quality, Manufacturing, Engineering or related field; Medical Device experience required
• 1-2 years of management experience.
• Excellent command of process validation and risk management for medical device.
• Thorough knowledge of applicable procedures, specifications, regulations, and standards.
• Demonstrated Experience managing quality personnel, specifically Quality Engineers, managing performance and developing teams.
• Demonstrated ability to work cross functionally and interact with plant and corporate personnel at all levels.
• Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact.
• Demonstrated capacity to develop validation strategy and lead team to execute.

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 base salary range of $80,000 to $180,000, plus an annual incentive bonus. The above range represents the expected base 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.

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 here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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