Sr Quality Engineer, Operations Development

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. 

Your Role at Baxter

Asa Senior Quality Engineer of Operations Development,you will be responsible for representing the quality function in planning, development, implementation, validation and support of new or improving processes supporting the launch of new or transferred products and product improvements. Lead compliance, investigations and corrective action projects on designated Quality process/area responsibilities with a focus on new process development and implementation. Lead assessments for regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies. Meets required timelines and effectiveness check metrics for all assigned projects and NCR/CAPA's.

Your Team at Baxter

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.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

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.

What You'll Be Doing

• Organize, review and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Ensure data integrity and compliance on initiatives to relevant systems, processes and equipment.

• Lead the development, review and approval of production and process control documentation including process and equipment validation, PFMEA, control strategy creation and process development.

• Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.

• Lead project monthly reviews of metrics and project status for the area. Decide on next steps and escalations for further review to improve the system, process or procedures.

• Organize, review, and update applicable Quality System Documentation. Support the data integrity initiatives to relevant systems, processes, and equipment.

• Evaluate all relevant operational data, reports, statistics, and documentation related to assigned investigation processes and projects for product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process.

• Lead NCR's, CAPA's and projects related to integration, remediation, or other items within a designated timeline to meet metric requirements through effectiveness checks.

• Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics. Document such actions within the quality system as appropriate (NCR/CAPA). Apply standard operating practices and problem-solving methodology.

• Assist in complaint/field return investigations related to manufactured product. Lead product projects monthly for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on cross-functional team responses and implementation of corrective actions.

• Lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.

• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas. Provide guidance to other Quality Engineers for their designated areas as required.

• Ability to provide requirements for change control based on procedural requirements.

What You'll Bring

• Bachelor Degree in Engineering having a minimum of 4+ years related experience or 2 years related experience with an advanced degree or proven performance and increasing responsibility within Quality roles.

• Six Sigma green belt or ASQ CQE certification highly desirable.

• Prior experience interacting with the FDA and other regulatory agencies a must.

• Ability to work effectively with multi-department and multi-site teams

• Ability to manage and organize complex technical problems

• Good written and oral communication skills, excellent attention to details

• Strong team leader with management skills and focus on results

• Strong scientific analysis and troubleshooting skills

• Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes

• Must have the ability to manage people, encourage teamwork and drive decisions.

Physical Demands

• Able to sit for long periods of time

• Must have good hand to eye coordination and dexterity

• Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

Work Environment

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

• 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.

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.

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 $88,000 - $121,000 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, commission, and/or long-term incentive. 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.

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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.