Quality Assurance Specialist

Job Description

Job Description

Quality Assurance Specialist

Location: Providence, RI 02907
Pay: $33 - $39 per hour
Schedule: Monday–Friday, 8:30 AM–5:00 PM
Employment Type: Temp-to-hire

Work Arrangement: Onsite preferred; hybrid may be considered

Connexion Systems & Engineering is seeking a Quality Assurance Specialist for a medical technology services company in Providence, RI.

This position supports the day-to-day operation of the Quality Management System (QMS), with a focus on corrective and preventive actions (CAPA), investigations, documentation, and audit support. The ideal candidate enjoys investigating problems, asks thoughtful questions, and can turn findings into clear, accurate written reports.

Responsibilities

• Support CAPA activities, including investigation writing, root cause analysis, development of corrective and preventive actions, and tracking actions through completion.
• Maintain electronic Quality Management System (eQMS) records, update documents, monitor due dates, and respond to quality-related requests.
• Log and review reported quality events and observations, including initial risk assessments.
• Compile, analyze, and present quality metrics for operational and management reviews, including CAPAs, audits, and nonconformances.
• Support complaint handling, supplier evaluations, and other quality system activities for internal teams and client projects.
• Participate in internal and external audits by preparing materials, coordinating documentation, and assisting with responses to auditor inquiries.
• Work across departments to gather information, address quality concerns, and keep investigations and required actions moving.
• Identify opportunities to improve QMS processes and support compliance with ISO 13485 and applicable quality system regulations.

Qualifications

• Approximately 2–5 years of relevant experience in a regulated industry.
• Strong business or technical writing skills, including the ability to clearly document investigations and explain quality findings.
• Experience supporting CAPA, root cause analysis, quality investigations, or related quality system activities.
• Ability to manage assigned tasks through completion with minimal supervision.
• Strong organizational skills and attention to deadlines and documentation accuracy.
• An inquisitive approach, willingness to ask follow-up questions, and persistence in resolving issues.
• Ability to collaborate with colleagues and handle difficult conversations professionally.
• Strong computer skills and comfort working with electronic systems, databases, and standard business software.

Preferred Qualifications

• Medical device or life sciences industry experience.
• Bachelor’s degree in business, engineering, life sciences, or a related technical discipline; not required.
• ISO 13485:2016 Internal Auditor Certification.
• Front-room or back-room audit experience.

Interview Process

Initial virtual interview, followed by an onsite second interview in Providence.

Apply with your resume highlighting your CAPA involvement, investigation writing, and quality systems experience.