Assoc, Quality

Baxter•Skaneateles Falls, NY

3d•Hybrid

About The Position

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.

Requirements

Associates degree required
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.
Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality is met.
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.

Nice To Haves

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

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.
Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training.

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
basic life, accident, short-term and long-term disability, and business travel accident insurance.
Flexible Spending Accounts
commuting benefits
the Employee Discount Program
the Employee Assistance Program (EAP)
childcare benefits