Quality Associate I

About the role

This job works under moderate supervision to apply practical professional knowledge of the Quality Assurance area to execute assigned tasks and manage defined project or process components including non-conformance investigations. Responsible for completing investigations including Root Cause Analysis and action plans.

Key Responsibilities

This job supports project outcomes including non-conformance investigation by completing defined tasks, collaborating with project leads and stakeholders, and following established processes and compliance requirements.

• Collaborates with colleagues to investigate non-conformance events, perform root cause analysis, action planning and assessments, ensuring processes are executed accurately and align with quality standards.
• Analyzes non-conformance (NC) events and NC trends to identify recurring issues and flag potential compliance risks for escalation and proper investigation.
• Conducts review of NC events such as verifying prior corrective action implementations per event and adherence to procedural requirements, to maintain process reliability.
• Develops detailed reports and records that clearly summarize audit Non-Conformance CAPA status and deviation data for review.
• Contributes to practical recommendations to improve specific processes, reduce recurring nonconformances, and support adherence to quality procedures.

Qualifications & Requirements

• Bachelors Degree in Engineering, science or closely related discipline is desired or equivalent technical experience plus demonstrated competence with a desired 5+ years of significant engineering/operational/laboratory/ experience.
• Has demonstrated competency within a discipline.
• Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within manufacturing, operations and QA and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others points of view and articulates tactfully and respectfully one's own perspective orally, in writing and in presentations.
• Works well with other colleagues in a collaborative fast-paced goal driven environment.
• Posses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in medical devices, pharmaceutical, biologics or similar industries (preferred).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.