Quality Assurance Associate

Duties and Responsibilities

• Collaborate on Quality processes, procedures, work instructions, and forms administer the CAPA, Deviation and NCMR processes.
• Work cross-functionally as part of a project team to aid departments in process improvement and procedure writing.
• Generate metrics for critical-to-quality process
• Participate in internal and external audits as required
• Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Affairs, and Regulatory to ensure continued compliance, product quality, and safety
• Address issues related to quality concerns, implementing effective solutions and corrective actions
• Review and approve internal CAPAs, Deviations, NCMRs and other quality processes as needed.
• Assist in Product Complaint investigations, Material, Change Review Boards as needed.
• Other duties, as required

Qualifications

• Bachelor’s degree or higher in Science or Engineering field
• 1 to 2 years QA experience in an ISO 13485 Certified or FDA regulated company
• Technical/Procedure writing, and process mapping experience
• IVD, molecular diagnostics/NGS, and/or software product experience
• Previous experience with root cause investigation, and process improvement
• ASQ certification (e.g., CQPA, CQIA, CQE, CQA, CQT)
Knowledge, Skills, and Abilities:
• Deep understanding of ISO 13485 and FDA QSR (21 CFR Part 820)
• Experience working in a regulated environment
• Bring a team spirit and problem-solving attitude 
• Competent in use of Microsoft Office software (Word, Project, Excel, Visio, PowerPoint)
• Familiarity with SAP or analogous Enterprise Resource Planning software systems, BSI Entropy electronic document system or a CAPA software systems, and quality improvement processes