Quality Assurance Specialist 2

Quality Assurance Specialist 2

Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients' innovations to market. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

Veranex has an exciting opportunity to join our team as a Quality Assurance Specialist 2. In this role, you will contribute to improving lives globally by supporting the delivery of compliant, high-quality medical technologies. The Quality Assurance Specialist 2 plays a key role in the day-to-day execution and maintenance of the Quality Management System (QMS), proactively supporting compliance with applicable national and international quality system regulations. This position supports QMS process management by performing system administration and data entry activities, monitoring timelines and performance metrics, assisting with reporting and analysis, and maintaining compliance with Quality System Regulation (QMSR) and ISO 13485 requirements. The role collaborates with internal stakeholders and client teams to support consistent, compliant, and effective quality practices.

What You Will Do:

• Perform day-to-day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality-related requests from staff and project teams.
• Support monthly operational and management review activities by compiling, analyzing, and presenting performance metrics for QMS processes such as CAPA, audits, nonconformances, RGAs, and other quality indicators.
• Log, triage, and perform initial risk assessments of reported quality events or observations in accordance with internal procedures and applicable regulatory requirements.
• Assist with investigations, root cause analyses, and the development, implementation, and tracking of correction, corrective action, and preventive action(s) related to audit findings, quality events, and CAPAs.
• Provide input and operational support for quality system activities, including complaint handling, CAPA processes, supplier evaluations, and other QMS activities, as needed to support client projects and internal quality objectives.
• Participate in internal and external audits, including preparation of audit materials, coordination of requested documentation, and timely responses to auditor inquiries.
• Contribute to continuous improvement of QMS processes by identifying opportunities for increased efficiency, compliance, or effectiveness and communicating findings to the quality team and management.

Required Qualifications:

• Bachelor's degree in business, engineering, life sciences, or a related technical discipline.
• 2-5 years of relevant experience in a regulated industry, preferably medical devices or life sciences.
• Ability to manage assigned tasks from initiation through completion with minimal supervision while meeting timelines and quality expectations.
• Strong written and verbal communication skills, with experience in business and/or technical writing and the ability to clearly communicate complex quality or regulatory information to both technical and non-technical audiences.
• Demonstrated curiosity and motivation to learn, investigate issues, understand root causes, and support preventive solutions.
• Strong computer literacy, including experience working with electronic systems, databases, and standard business software.

Preferred Qualifications:

• ISO 13485:2016 Internal Auditor Certification
• Back or Front Room Audit Experience

Location:

• This position is an onsite role with hybrid capabilities and can be in either Providence, RI or Raleigh, NC.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.