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’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s 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— where your purpose accelerates our mission.
Job Title: Associate II, Quality
Job Profile: Prof II-Quality-General Quality-Ex
Supervisor’s Title: Manager I, Quality
Function Quality
FLSA: Exempt
Grade Profile: 16-QGRAL-USA

Job Responsibilities

• Lead daily departmental activities for areas of Receiving and Incoming Inspection
• Create and / or analyze operation metrics and reports to identify improvement opportunities
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

Knowledge, Skill and Abilities

• Working knowledge of medical products
• Excellent computer skills
• Knowledge of JDE (GME Business Application)
• Good communication, written and oral skills
• Knowledge of regulations outside United States a plus
• Self-motivated with the ability to work independently and make decisions
• Excellent organizational skills, problem solving skills and attention to detail
• Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment.
• Ability to drive decisions and actions.
• Expertise in interpreting regulations and familiarity with GDP and GMP
• Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806, 810, 820 strong preferred.

Required Education and Experience

• BS in business or science or equivalent
• 3-5 years of experience in Quality with a medical device / Pharma company or other similarly regulated industry.

• Lead daily departmental activities for areas of Receiving and Incoming Inspection
• Create and / or analyze operation metrics and reports to identify improvement opportunities
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items