QA Associate II - CAPA & QMS Investigator (Temp/Temp-Hire)

Connexion Systems and Engineering, Inc.; Providence (RI); In loco; USD 41.000 - 55.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality Assurance

CAPA investigations

Root cause analysis

Technical writing

eQMS

Formazione

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

Strumenti

eQMS software

ISO 13485 familiarity

Descrizione del lavoro

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.