Job Description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

This is where your creativity addresses challenges

The Associate, Quality Systemsat Baxter, is responsible for supporting day-to-day quality system activities for the site by maintaining quality assurance processes for accuracy, conducting investigations and reports, and working cross-functionally to ensure compliance with quality standards and regulatory requirements. This role will focus on one or two of the following key areas of the quality system: Management Responsibility, Training & Document Control, Change Control, legal manufacturer activities, and regulatory compliance. In this role, the Quality Systems Associate will communicate, coordinate, and collaborate cross-functionally, and support critical initiatives and projects to meet key performance objectives. This role is essential to maintaining product integrity, supporting continuous improvement and driving compliance excellence in a fast-paced medical device facility.

This role is a hybrid role, with 3 days on-site in Skaneateles Falls, New York, and has opportunities for growth and development in a continuous improvement and innovative environment focused on people, process and performance.

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 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.

What we offer from Day One

• 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

What you'll be doing

Training System Administration

• Submit and manage BAXU system tickets for training updates, curriculum changes, and user issues.
• Maintain training assignments, training records, and ensure accuracy of employee training curricula.
• Track and trend training compliance metrics, including overdue training and upcoming training.
• Generate routine training status and compliance reports for supervisors and QA leadership.
• Coordinate training assignments in the LMS and ensure training completion for new or revised procedures.
• Support training record accuracy and help ensure employees remain in compliance with required quality training

QMS & Change Control Management

• Assist with routing, tracking, and closing change requests and change controls within the QMS.
• Ensure change control documentation is complete, accurate, and compliant with internal procedures.
• Support QMS-related administrative tasks such as updating documents, verifying attachments, and following up with stakeholders.
• Maintain Quality Metrics for change of timeliness and make recommendations for improvement.
• Support the initiation, documentation, and tracking of related non-conformances (NCRs) and deviations within TrackWise.
• Assist with gathering data, attachments, and required information from production, engineering, and quality teams.
• Ensure timely routing and closure of NCRs/deviations by following up with responsible SMEs.

Document Control Activities

• Route controlled documents for review, approval, issuance, and archival.
• Maintain organized, compliant document files in accordance with internal SOPs.
• Perform routine periodic document reviews, verifying accuracy, relevance, and compliance.
• Ensure documents follow internal formatting standards and regulatory requirements.

Management Review

• Coordinate with cross-functional departments to compile and prepare Management Review (Quarterly).
• Provide support for all Management Review activities for the site.
• Ensure that all Management Review activities are conducted in accordance with regulatory requirements and company policies.

Process/Quality Improvements

• Assist with the monitoring, tracking, and reporting of quality initiatives, including Site Strategic Improvement Plans, Quality Plans, and Corrective Actions.
• Identify areas for process/quality improvements and support those efforts.
• Collaborate with cross-functional teams to implement process/quality improvements.

External Assessments and Audits

• Participate in internal and external audits by providing documentation, explaining processes, and supporting requests.
• Support process with timely closure of observations/audit items.
• Document the audit schedule and summarize observations for the executive team.

Risk Management

• Support risk analysis for products for both the site level and to the corporate team for feedback.
• Collaborate with cross-functional teams to ensure that all necessary risk assessments are completed and that all necessary regulatory submissions are made.

Safety and Regulatory Compliance:

• Proactively contributes to zero harm in the workplace for all employees by complying with legal and corporate (EHS) Environmental Health & Safety requirements, safe work practices, and EHS policies and procedures consistently.
• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment.
• Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality is met.
• Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training.

What you'll bring

• Associates degree required; bachelor’s degree in a related field (e.g., engineering, quality assurance, science) preferred.
• 1+ year of experience in quality assurance in a regulated industry preferred.
• Quality assurance certification, such as CQA or CQE or a Lead Auditor Certification preferred.
• Experience with quality management systems, including experience in implementing and maintaining quality management systems preferred.
• Good understanding of quality assurance principles and methodologies, as well as regulatory requirements (e.g., FDA, ISO 13485).
• Must be able to handle multiple projects concurrently.
• Excellent attention to detail and analytical skills, with the ability to identify defects and non-conformities.
• Strong communication and interpersonal skills, including experience in working with cross-functional teams.
• Strong analytical and problem-solving skills, including experience in identifying and resolving quality issues.

Work Environment:

The Quality Associate at Baxter may work in the following environments:

• Office Setting Working in an office setting, potentially up to 80% of the time, reviewing documents, conducting data analysis, and participating in meetings.
• Manufacturing Environment Working in a manufacturing environment, potentially up to 10% of the time, conducting audits and inspections.
• Warehouse Environment Working in a warehouse environment, potentially up to 5% of the time, conducting audits and inspections.
• Traveling Traveling to conferences, training sessions, and other locations, potentially up to 5% of the time, attending meetings, participating in training, and conducting audits and inspections.
• Temperature Extremes Working in temperatures that may be hot or cold, potentially up to 10% of the time.
• Humidity Working in humid environments, potentially up to 10% of the time.
• Noise Working in noisy environments, potentially up to 10% of the time.
• Chemical Exposure Exposure to chemicals, potentially up to 5% of the time.
• Biological Exposure Exposure to biological materials, potentially up to 5% of the time.

The Quality Associate at Baxter may be required to:

• Wear Personal Protective Equipment (PPE) Wear PPE, such as gloves, safety glasses, and a hard hat, to protect themselves from potential hazards.
• Follow Safety Procedures Follow safety procedures, such as lockout/tagout and confined space entry, to ensure their safety and the safety of others.
• Maintain Confidentiality Maintain confidentiality of sensitive information, such as supplier information and company data.

The Quality Associate at Baxter may be required to perform the following physical demands:

• Standingand walking for extended periods of time, potentially up to 8 hours per day, to attend meetings, conduct audits, and inspect facilities.
• Sitting Sitting for extended periods of time, potentially up to 6 hours per day, review documents, conduct data analysis, and participate in meetings.
• Lifting and Carrying Lifting and carrying documents, equipment, and other materials, potentially up to 25 pounds, to conduct audits and inspections.
• Bending and Stooping Bending and stooping to access equipment, documents, and other materials, potentially up to 2 hours per day.

The above description outlines the primary responsibilities of the role but does not preclude the assignment of additional tasks as needed. Previous iterations of this job description are incorporated and may be assigned based on operational requirements. Any such inclusions will align with the established factor of degrees for this position.

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 $68,000 - $93,500 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 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.

Know Your Rights: Workplace Discrimination is Illegal

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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