Senior Quality Engineer

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

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior Quality Engineer, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. This role may mentor newer Quality Engineers as needed. The job contributes engineering/technical expertise through the Quality function to the manufacturing facility. The Quality Engineer's duties not only include traditional work and projects, such as optimization, defect analysis, and prevention, and exception management, but also may encompass project engineering work as well, including the procurement of funding for capital investment, ROI analysis, research of the optimum equipment for the task, and implementation of that equipment. The Quality Engineer is accountable for the validation process. The job requires basic engineering skills, statistical/six sigma skills, numerical analysis techniques and implementation skills for process improvement. Knowledge of current validation requirements is a must, from the design phase of the project to continued process verification.

The Senior Quality Engineer should have adequate knowledge of one or more of the following: Filling Equipment, Packaging Equipment, Automation/Control Systems Validation, Process Compressed Gas systems, HVAC systems for controlled environments and subsequent monitoring, as well as compendia water purification systems. A basic understanding of microbiology and potential contamination sources is required. Additional areas of knowledge and experience should include terminal sterilization and pest control. Interfacing with outside regulators and auditors may be required.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

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.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• Leads or assists in developing and implementing new machines/processes and in improvements to existing methods. Qualification requirements for new/improved machines/processes, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Senior Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives improvements.
• Manage small projects (both new and improvement) to include cost, implementation, and validation.
• Provides statistical assistance to Quality and Production.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Supports and may own execution of CAPA investigations with use of DMAIC process and technical writing skills.
• Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
• Understanding and knowledge of various international standards relating to a variety of topics, as needed (i.e. ASTM, ASRAE, ANSI, AAMI, ISO standards applicable to scope of work)
• Responsible for:
• Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
• Identifying problems relating to the product, process and quality system.
• Initiating and implementing solutions through designated channels.
• Establishing controls on a process and establishment of the verification/monitoring of such.
• Driving improvements into the production process, from conception to sustainable production methods.

• Minimum 6 years of experience in regulated manufacturing environment
• BS degree in Engineering preferred, Engineering Technology / Biology / Microbiology/Chemistry degree may be acceptable depending on experience.
• Strong technical writing and investigation skills required.
• Computer proficiency in Microsoft Word, Excel, Project, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked 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 $80,000 - $110,000 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. 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: 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
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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

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