Pharmavise Corporation

Manage CAPAs, conduct risk assessments and root cause analysis, maintain quality documentation, and collaborate across teams to ensure quality compliance. | Bachelor’s degree in biomedical engineering or related field, 5+ years quality engineering experience in life sciences, strong technical writing and risk management skills. | This is a remote position. Our Biomedical Device client has an exciting opportunity for a Quality Engineer II. Job Summary: We are seeking two highly skilled Quality Engineers (Level II) to support a 6-week project. This is a full-time (40 hours per week), remote contract role. The ideal candidates will bring strong technical expertise in biomedical engineering and quality systems, with proven experience in CAPA development, risk management, and process documentation. Responsibilities: • Draft and manage CAPAs (Corrective and Preventive Actions), including conducting detailed root cause analysis. • Perform risk assessments, update Hazard Analyses, and maintain pFMEAs to ensure compliance with industry quality standards. • Produce clear, detailed, and accurate technical documentation. • Follow technical direction effectively while independently contributing to project deliverables. • Collaborate with cross-functional teams (Quality, Regulatory, Engineering, Operations) to drive quality improvements and ensure alignment with project goals. Required Qualifications: • Bachelor’s degree in Biomedical Engineering or related technical discipline (preferred). • More than 5 years of experience in Quality Engineering within the life sciences industry strongly preferred. • Strong technical writing skills for CAPA and compliance documentation. • Hands-on experience with: o Drafting and managing CAPAs with root cause analysis o Conducting risk assessments and updating Hazard Analyses o Maintaining and revising pFMEAs • Excellent communication and interpersonal skills; proven ability to collaborate across departments. • Detail-oriented, self-motivated, and able to manage workload in a remote environment. Other Details: • Project Length: 6 weeks • Start Date: ASAP • Full-time (40 hours/week) • Work Arrangement: 100% remote