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About the Role

The Associate, Quality Systems at 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 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.

Requirements

• 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.
• 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.

Skills

• Quality assurance
• Quality management systems
• FDA
• ISO 13485
• Risk management
• Good Manufacturing Processes (GMP)
• Environmental Health & Safety (EHS)

Location

• Skaneateles Falls, New York

Work Type

• Hybrid

Experience Level

• 1+ year of experience in quality assurance in a regulated industry preferred.
• Associates degree required; bachelor’s degree in a related field (e.g., engineering, quality assurance, science) 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.

Education Level

• Associates degree required; bachelor’s degree in a related field (e.g., engineering, quality assurance, science) preferred.

Salary/Compensations

• $68,000 - $93,500 annually

Benefits

• 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
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• 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
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits

About the Company

• 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.
• 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.

Equal 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
• 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.