Quality Associate III

·         Strong critical-thinking, analytical, and problem-solving skills with the ability to independently evaluate complex or ambiguous situations.

·         Demonstrated ability to own and manage quality-system processes and drive measurable, sustainable improvement.

·         Sound judgment and demonstrated ability to make risk-based quality decisions within delegated authority.

·         Strong knowledge of medical device quality-system requirements, including applicable FDA requirements, ISO 13485, Good Manufacturing Practices, Good Documentation Practices, and data integrity principles.

·         Experience with investigations, root-cause analysis, CAPA, change control, risk management, audits, validation, procedure development, training controls, and quality metrics.

·         Proven ability to influence cross-functional stakeholders, constructively challenge ineffective practices, and drive accountability without direct authority.

·         Strong technical-writing, communication, project-management, and organizational skills.

·         Ability to manage multiple priorities and work independently across a matrixed organization supporting multiple depot locations.

·         Ability to communicate effectively with depot personnel, process owners, functional leaders, senior management, auditors, and inspectors.

·         Ability to travel to U.S. depot locations and, as needed, support activities that promote consistency and alignment across UCAN depot operations.

·         Primary work location: Skaneateles Falls, New York.

·         Travel to U.S. depot locations and, as needed, support activities that promote consistency and alignment across UCAN depot operations. Recommended posting language: up to 25%.

·         Hybrid or onsite expectations will follow the applicable Baxter workplace policy and operational requirements.

·         No direct supervisory responsibilities. The role may provide work direction, technical guidance, training, and approval of work performed by others within delegated Quality authority.

·         Adheres to all environmental, health, safety, data integrity, and Good Documentation Practice requirements. Performs other duties as assigned.

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 $96,000-132,000 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.