Quality Assurance Associate 2

Connexion Systems & Engineering Inc.; Providence (RI); On-site; USD 41,000 - 55,000; Full time

Job summary

Connexion Systems & Engineering is seeking a Quality Assurance Associate II to support QMS activities in a regulated medical technology environment. The role emphasizes CAPA management, investigations, root-cause analyses, and technical writing to ensure compliance.

The ideal candidate will be curious, have strong written communication, and collaborate across teams to resolve quality issues and drive improvements. Salary is hourly with onsite preference; hybrid may be considered.

Qualifications

• 2–5 years of QA experience in regulated industries (medical device or life sciences preferred).
• Strong technical and business writing for investigations and quality info.
• Experience with CAPA, investigations, root cause analysis, and QMS.

Responsibilities

• Maintain and administer the QMS (eQMS data entry, documents, records, due dates).
• Participate in CAPA investigations and prepare related actions.
• Log, triage, and assess quality events and observations.

Skills

Quality Assurance

CAPA investigations

Root cause analysis

Technical writing

QMS

Education

Bachelor’s degree in related technical discipline

Tools

eQMS

Job description

• Title: Quality Assurance Associate II


• Hiring Organization: Connexion Systems & Engineering


• Compensation, Benefits, and Employment Type: Temp or Temp-to-Hire


• Pay rate: $30–$40/hour


• Job Location: Providence, RI (preferred) or Raleigh, NC


• Work Model: Onsite preferred; hybrid may be considered


• Schedule: Monday–Friday, 8:30 AM–5:00 PM

We are seeking a Quality Assurance Associate II to support Quality Management System (QMS) activities within a regulated medical technology/life sciences environment. This role will have a strong focus on CAPA management, investigations, root cause analysis, technical writing, and overall QMS compliance. The ideal candidate is naturally curious and inquisitive, has excellent written communication skills, and is comfortable digging into quality issues to identify root causes and drive effective solutions. We’re looking for someone who is collaborative and persistent and can confidently ask difficult questions when necessary to ensure quality and compliance.

Responsibilities

• Perform day-to-day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring due dates, and responding to quality-related requests.


• Participate in and write CAPA investigations, root cause analyses, corrections, corrective actions, and preventive actions.


• Log, triage, and perform initial risk assessments of reported quality events and observations.


• Compile, analyze, and present QMS performance metrics, including CAPAs, audits, nonconformances, and other quality indicators.


• Support complaint handling, supplier evaluations, and other QMS activities.


• Participate in internal and external audits, including audit preparation, documentation coordination, and responses to auditor inquiries.


• Track quality actions and investigations through completion while ensuring established timelines are met.


• Identify opportunities to improve QMS efficiency, compliance, and effectiveness.


• Collaborate with internal teams and stakeholders to investigate and resolve quality issues.

Qualifications

• 2–5 years of relevant Quality Assurance experience in a regulated industry; medical device or life sciences experience preferred.


• Strong technical and business writing skills with the ability to clearly document investigations and quality-related information.


• Experience with CAPA, investigations, root cause analysis, and Quality Management Systems.


• Familiarity with ISO 13485 and/or Quality Management System Regulation (QMSR) requirements.


• Strong investigative skills and a genuine interest in understanding why issues occur.


• Ability to independently manage assigned tasks from initiation through completion.


• Collaborative and persistent approach with the ability to navigate challenging conversations.


• Strong computer literacy, including experience with electronic systems, databases, and standard business software.


• Bachelor’s degree in business, engineering, life sciences, or a related technical discipline preferred, but not required.

Preferred Qualifications

• ISO 13485:2016 Internal Auditor Certification.


• Front-room or back-room audit experience.