Your role at Baxter
This document outlines the employment prerequisites and job responsibilities for the Quality Assurance Systems Engineer position.
What You'll Be Doing
Reporting to the QA Systems Manager, the primary responsibilities are:
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
What You'll Bring
Bachelor's degree in Engineering. 1-3 years of engineering experience preferred.
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.
Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and applying engineering principles.
Basic understanding of validation guidelines, cGMPs Regulations, and Good Manufacturing Practices, preferred.
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.
PHYSICAL DEMANDS
Must be able to sit, stand, or walk throughout the workday.
Ability to lift and carry up to 20 pounds and perform repetitive hand/finger motions.
Good hand-eye coordination and dexterity required.
Dynamic lifting capability: lift 15 pounds floor to shoulder, 2 pounds overhead; push/pull with up to 6 pounds of force.
WORK ENVIRONMENT
The work environment is a regulated manufacturing facility governed by FDA and internal quality standards. Employees are expected to comply with all applicable rules and procedures designed to maintain product integrity and safety.
Conditions and requirements include:
Wearing a static protective smock and wrist strap while in designated areas.
Working in close proximity to others in a temperature- and humidity-controlled environment.
Compliance with cleanroom or ESD (electrostatic discharge) protocols as required.
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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $ $76,000-$104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
