Quality Analyst

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.

Provide Quality support and oversight of process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements.

Within Quality, every role makes a difference! Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

• Leads ongoing, daily departmental operations.

• Perform in depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems, and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet all requirements.

• Lead internal production line and product audits. Report out on results. Support external assessments or audits.

• Lead Material Review Board (MRB) weekly review meetings and promote non-conforming product processes. Prevent further shipments and/or processing of materials in the event of encountering non-conforming product.

• Assist with audits of various reports (Protocols, Qualifications, Regulatory, Submissions, etc.)

• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant areas.

• High school degree or GED required.

• Bachelor's degree with 0-2 years' experience, Associates degree with 2-6 years' experience, or 6+ years Quality experience with a medical device/pharma or other similarly regulated industry required.

• Strong interpersonal skills and phenomenal attention to detail.

• Proven track record to handle multiple projects concurrently.

• Have solid understanding of FDA Regulations, Application of Good laboratory Practices, and Application of Good Manufacturing Practices.

• Must be a strong team player with good problem solving and good verbal and written communication skills.

• Can encourage teamwork and drive decisions.

Physical Requirements:

• Ability to sit, stand or walk for long periods.

• Must have good hand to eye coordination and dexterity

• The worker is required to have natural or corrected near-distance visual acuity of 20/25 and ability to differentiate between colors.

• Dynamic Lifting capability: Must have the ability to lift 40 pounds.

Work Environment:

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.

• Wearing a static protective smock at all times while in the work area

• Wearing a ground wrist strap and plugging that wrist strap into the working table.

• Working in close proximity to other employees.

• Working in an environment that is temperature and humidity controlled.

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 salary range of $60,000 to $82,500 and also includes an annual incentive bonus. The above range represents the expected 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.

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: Benefits | Baxter

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.