Quality Assurance Associate 2 - CAPA Owner/Coordinator

Job Description

Job Description

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.

Title: Quality Assurance Associate II

• Schedule: Monday–Friday, 8:30 AM–5:00 PM
• Looking for someone with demonstrated experience leading and executing CAPAs both as the primary owner and coordinator.
• This person is responsible for CAPA system, participating, writing investigations etc.
• Must have: Ability to write
• Someone who’s truly interested in being inquisitive
• BA degree preferred not required
• Experience 2-5 of relevant experience
• Collaborative, push buttons, be able to have difficult conversations, persistent

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.
• 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.