About This Role

Veranex has an exciting opportunity to join our team as a Quality Assurance Specialist 2. You will be part of a team working to improve lives globally through medical technology innovation. The Quality Assurance Specialist proactively manages the various elements of the quality system to ensure compliance with applicable national and international quality system regulations. This position supports cleanroom monitoring, Preventive Maintenance, quality control, equipment control processes, and maintains QSR/ISO 13485 Quality Systems compliance.

What You Will Do

• Ability to support monthly operations and management review meetings by compiling and presenting metrics for NCRs, OOTs, PMs, etc.
• Perform Risk Assessments for quality observations.
• Support process risk management for novel and existing medical devices (PFMEA)
• Develop, document, and validate inspection and test methods to support design control, Process Validation, part qualification, in-process inspection, and final inspection activities.
• Provide input and/or oversight into quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.
• Support Quality Control activities such as calibration, preventative maintenance, and inspections.
• Participate in continuous improvement efforts related to quality processes.

Required Qualifications

• Bachelor’s degree in engineering or life sciences
• 2-4 years of relevant experience in medical devices
• Strong investigational and communication skills, with a strong skillset to document investigations, perform root cause analysis, and determine corrective action plans
• Strong knowledge of medical device regulations and standards
• Strong knowledge of medical device regulations, guidance documents, and standards (i.e., quality system regulations (QSR) International Organization for Standardization (ISO) 13485, ISO 14971, and guidance documents as needed)

Preferred Qualifications

• Experience with different quality management systems
• Provides risk management expertise in the evaluation and design of products
• Experience in design verification and/or validation

Location

• This is an onsite position in Providence, RI