QA Systems Engineer

Baxter International Inc.•Medina, NY

1d•$76,000 - $104,500•Onsite

About The Position

This document outlines the employment prerequisites and job responsibilities for the Quality Assurance Systems Engineer position. 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.

Requirements

Bachelor's degree in Engineering.
1-3 years of engineering experience preferred.
Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and applying engineering principles.
Experienced multitasker with solid prioritization skills is essential
Support plant initiatives with the development and implementation of new processes/technologies
Highly motivated to learn and accomplish goals.
Ability to meet tight deadlines.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Prefer experience and/ or training with process improvement methods (e.g. six sigma, lean)
Interest in obtaining certifications (ASQ)
Experience in the manufacturing and/or medical device industry preferred, including experience in the development and deployment of Quality Systems.
Basic understanding of validation guidelines, cGMPs Regulations, and Good Manufacturing Practices, preferred.

Responsibilities

Support and execute complex validations, including IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems within the facility throughout the validation stages with little or no guidance.
Own and drive change control based on procedural requirements
Assist, present, defend, and communicate with external auditors and other validations or projects in which you lead or participated.
Assist or lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.
Work collaboratively with a cross-functional team (production, quality, laboratory, etc.)
Apply solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools and/or specialties such as electrical, mechanical, chemical, industrial, or biological).
Assists in the preparation and participation of technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.
Assist management or other engineers during process design, equipment installation, qualification, and/or process monitoring.
Provide technical reports and/or data-driven analysis after training.
Other duties as assigned

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits