Senior Director, Quality Assurance - Medical Devices

Viant Medical; Fremont (CA); On-site; USD 200,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k Plan with Company Match

Paid time off and holidays

Tuition Reimbursement

Voluntary Life and Long-Term Care

Pet Insurance

Home Ownership Program

Job summary

Viant Medical in Fremont, California, is seeking a Director of Quality Assurance to lead a quality engineering team of about 15 and to oversee the company’s Quality Management System across both product development and manufacturing operations.

The candidate must have deep FDA 21 CFR 820 and ISO 13485 expertise, strong leadership, and a track record of driving CAPA, audits, change control, and regulatory compliance while partnering with customers and suppliers to ensure product quality.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 10+ years of quality experience in regulated manufacturing and development environments.
• 5+ years leading quality teams in medical device or related industries.
• Strong knowledge of FDA and ISO 13485, CAPA, NCR, and audits.
• Customer-facing quality leadership experience.

Responsibilities

• Provide strategic leadership for Quality Assurance programs and policies.
• Lead design, implementation, and maintenance of document control, training, CAPA, discrepancy, and complaint systems.
• Guide all departments on quality and regulatory requirements.
• Develop and maintain quality system procedures and lead QA/RA document reviews.
• Manage Quality Engineering support and assist Quality Inspection teams.
• Partner with management to drive KPIs and process adherence.
• Collaborate with customers and suppliers on quality matters and maintain relationships.
• Direct selection, training, and development of QA personnel; coach and mentor.
• Maintain QMS compliant with FDA 21 CFR 820 and ISO 13485; ensure customer satisfaction.
• Oversee audits, CAPA programs, changes, and responses to customer quality data.

Skills

Leadership

Communication

People management

Coaching

Team development

Education

Bachelor's degree in Engineering, Quality, or related field

Tools

CAPA management

Document control systems

Job description

Viant Medical in Fremont, California, is seeking a Director of Quality Assurance to lead a quality engineering team of about 15 and to oversee the company’s Quality Management System across both product development and manufacturing operations.

The candidate must have deep FDA 21 CFR 820 and ISO 13485 expertise, strong leadership, and a track record of driving CAPA, audits, change control, and regulatory compliance while partnering with customers and suppliers to ensure product quality.