Quality Assurance Associate 2

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

Job summary

Connexion Systems & Engineering seeks a Quality Assurance Associate II to support QMS activities in a regulated medical technology environment, focusing on CAPA, investigations, root cause analysis, technical writing, and overall QMS compliance.

The ideal candidate is curious, with strong written communication skills, collaborative, and able to drive quality improvements while maintaining compliance within ISO 13485 guidelines.

Qualifications

• 2–5 years of Quality Assurance experience in a regulated industry (medical device or life sciences preferred).
• Strong technical and business writing skills for documenting investigations and quality information.
• Experience with CAPA, investigations, root cause analysis, and QMS requirements (ISO 13485 and QMSR).
• Independent task management from initiation to completion.
• Collaborative, persistent attitude with ability to navigate challenging conversations.

Responsibilities

• Maintain and administer the QMS (eQMS data entry, document updates, records management, due-date monitoring).
• Participate in CAPA investigations, root cause analyses, corrections and preventive actions.
• Log, triage, and assess quality events and observations.
• Analyze and present QMS metrics (CAPAs, audits, nonconformances).
• Support complaint handling and supplier evaluations.
• Assist in audits, including preparation and responses to inquiries.
• Track actions and investigations to completion within timelines.

Skills

Quality Assurance

CAPA investigations

Root cause analysis

Technical writing

eQMS

Education

Bachelor’s degree in business, engineering, life sciences, or related technical discipline

Tools

eQMS software

ISO 13485 familiarity

Job description

• Duration: 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
• Job#: bh19641

Title: Quality Assurance Associate II

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, And Employment Type

• Duration: 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
• Job#: bh19641

Description

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.
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• 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.

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.