Senior Quality Engineer: CAPA, Validation & Audits

Viant Medical; Fremont (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Company-paid life insurance and DIS

Generous paid time off and holidays

401k Plan with Company Match

Tuition Reimbursement

Voluntary Universal Life and Long-Term

Job summary

Viant Medical in Fremont, CA seeks a Sr. Quality Engineer to lead quality activities across NCRs, complaints, CAPA and validation efforts. You will own quality subsystems, drive PFMEAs and control plans, and report metrics with cross‑functional teams.

Healthcare device experience is preferred and leadership of inspections is expected. You’ll collaborate on continuous improvement, supervise inspectors or technicians, and ensure compliance with QMS and regulatory standards, while maintaining

Qualifications

• Bachelor's Degree or equivalent experience.
• 7–10 years in Quality or related engineering roles within manufacturing environments.
• Ability to lead root cause analysis with cross‑functional teams and drive corrective/preventive actions.
• Experience in medical device manufacturing or similar plastics/chemicals environments.
• Proficient with data analysis (Excel; Minitab preferred) to inform decisions and reports.
• Experience producing validation reports and translating results into documentation.
• Strong time management, proactive ownership, and adaptability to changing priorities.
• Familiar with QMS and regulatory quality systems.

Responsibilities

• Open, investigate, and close NCRs.
• Open, investigate, and close complaints.
• Create metric reports as assigned.
• SPC monitoring and data-driven improvements.
• Participate in CAPA projects and root cause analyses.
• Participate in validation and measurement capability projects.
• Update procedures as required.
• Lead continuous improvement initiatives across the product line.
• Own key quality subsystems and drive validations.
• Create control plans and PFMEAs.
• Perform internal audits and supplier qualifications.
• Act as SME during regulatory inspections.
• Lead Drumbeat customer meetings and report progress.

Skills

Root cause analysis

CAPA

Statistical analysis

Quality systems

Cross-functional leadership

Project management

Data analysis (Excel)

Validation reporting

Education

Bachelor's degree

Tools

Minitab

Microsoft Office

Job description

Viant Medical in Fremont, CA seeks a Sr. Quality Engineer to lead quality activities across NCRs, complaints, CAPA and validation efforts. You will own quality subsystems, drive PFMEAs and control plans, and report metrics with cross‑functional teams.

Healthcare device experience is preferred and leadership of inspections is expected. You’ll collaborate on continuous improvement, supervise inspectors or technicians, and ensure compliance with QMS and regulatory standards, while maintaining