Quality Compliance Associate

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity.

Responsibilities

• Supports the maintenance of the site Quality Management System (QMS) to ensure compliance with applicable regulations, standards, and internal procedures.
• Assists with complaint intake, documentation, investigation support, and timely closure in accordance with complaint handling procedures.
• Supports the initiation, review, processing, and completion of Nonconformance (NC) records in the electronic quality system.
• Gathers information and supporting data for complaint investigations, NCs, and CAPAs, and assists with root cause analysis activities.
• Maintains quality system documentation, including procedures, forms, and records, ensuring accuracy and document control compliance.
• Assists with quality data collection, trending, and reporting of quality metrics in accordance with established procedures.
• Provides quality assurance support to manufacturing, product development, and other functional areas by addressing quality questions and ensuring procedural adherence.
• Supports internal and external audits by preparing documentation, responding to requests, and participating as needed.
• Participates in quality-focused meetings, communicates status updates, and tracks actions to completion.
• Escalates potential quality issues, compliance risks, or delays to senior quality personnel in a timely manner.
• Participates in continuous improvement activities and special projects as assigned.
• Completes required training and maintains awareness of applicable quality system requirements and regulatory expectations.

Requirements

• Associate’s degree in a scientific, technical, or related discipline or a minimum of 2 years of experience working within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, or similar).
• Previous experience supporting quality systems, complaint handling, nonconformance management, or documentation control preferred.
• Basic understanding of regulated quality environments (e.g., FDA, ISO, or similar standards).
• Strong attention to detail and organizational skills with the ability to manage multiple tasks and meet deadlines.
• Effective written and verbal communication skills.
• Ability to clearly document findings and follow established procedures.

Qualifications

• Must be able to read and write in English.

Skills

• Attention to detail
• Organizational skills
• Communication skills
• Quality system knowledge

Benefits

• Medical
• Dental
• Vision
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))

Pay

Pay Range: $62,100.00 - $85,100.00 USD