Quality Assurance Associate

Job Description

Job Description

Quality Assurance Associate II
Location: Providence, RI or Raleigh, NC (Hybrid flexibility may be considered)

Rate: 30-40/hr
Employment Type: Contract-to-Hire
Status: Priority Opening

Position Summary

A growing organization within the medical technology and life sciences industry is seeking a Quality Assurance Associate II to support Quality Management System (QMS) activities and regulatory compliance initiatives. This role is responsible for maintaining quality systems, supporting investigations, managing CAPA processes, assisting with audits, and helping ensure compliance with applicable quality and regulatory standards.

Key Responsibilities

• Maintain and administer QMS processes, including electronic quality systems, document control, records management, and quality-related requests.
• Track and monitor quality system metrics and prepare reports for operational and management reviews.
• Log, assess, and triage quality events and observations.
• Support investigations, root cause analyses, corrective actions, and preventive actions (CAPA).
• Assist with complaint handling, supplier quality activities, and other quality system processes.
• Participate in internal and external audits, including audit preparation and follow-up activities.
• Identify opportunities for continuous improvement within quality systems and processes.
• Collaborate with cross-functional teams to support quality and compliance objectives.

Required Qualifications

• 2 to 5 years of experience in a regulated industry, preferably medical devices, pharmaceuticals, biotechnology, or life sciences.
• Strong technical and business writing skills.
• Experience supporting investigations, CAPA programs, and quality systems.
• Ability to work independently and manage multiple priorities.
• Strong communication and interpersonal skills.
• Proficiency with electronic systems, databases, and standard business software.
• Demonstrated curiosity, critical thinking, and problem-solving abilities. [Job #19641...ssociate 2 | Outlook]

Preferred Qualifications

• Bachelor's degree in a technical, scientific, engineering, or business-related discipline.
• ISO 13485 Internal Auditor certification.
• Experience participating in regulatory or quality audits, including front-room or back-room audit support.

Work Environment

• Standard Monday through Friday schedule.
• Preference for onsite collaboration, with potential hybrid flexibility depending on location and business needs.
• Opportunity to contribute to products and technologies that improve patient outcomes and healthcare innovation.