Assoc, Quality

About the role

This is where your creativity addresses challenges. 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. 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.

Responsibilities

• 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.
• 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.
• Document Control Activities: Route controlled documents for review, approval, issuance, and archival. Maintain organized, compliant document files in accordance with internal SOPs.
• Management Review: Coordinate with cross-functional departments to compile and prepare Management Review (Quarterly). Provide support for all Management Review activities for the site.
• Process/Quality Improvements: Assist with the monitoring, tracking, and reporting of quality initiatives, including Site Strategic Improvement Plans, Quality Plans, and Corrective Actions.
• 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.
• 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.

Requirements

• Associate's 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, Manufacturing Environment, Warehouse Environment, and Traveling. The Quality Associate at Baxter may be required to wear Personal Protective Equipment (PPE), follow safety procedures, and maintain confidentiality.

The Quality Associate at Baxter may be required to perform the following physical demands: Standing and walking for extended periods of time, sitting, lifting and carrying, bending and stooping.

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

Pay

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.