Lead Supplier Quality Engineer, Medical Devices

Imperative Care; Campbell (CA); On-site; USD 150,000 - 167,000; Full time

Benefits offered by this job

Stock options

401k plan

Health benefits

Generous PTO

Parental leave program

Job summary

Imperative Care in Campbell, California is seeking a Staff Supplier Quality Engineer to join our on-site, full-time team. You will provide supplier quality engineering support across development, manufacturing, and distribution of our medical devices.

The role emphasizes adherence to ISO 13485 and FDA regulations, supplier audits, change management, CAPA/NCMR, and collaboration with Procurement, R&D, and Operations to prevent disruptions.

Qualifications

• BS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years
• Experience with catheters, endovascular or neurological devices
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485
• Excellent written and verbal communication skills
• Ability to manage multiple tasks concurrently with accuracy

Responsibilities

• Provide Supplier Quality Engineering support in development, manufacture, and distribution of medical device products; ensure compliance with ISO 13485, FDA and other regulations
• Collaborate with suppliers to ensure robust materials, products, processes, and systems
• Lead supplier change management including notification, impact assessment, and approvals
• Manage supplier issues and drive corrective actions with root cause analysis
• Plan, conduct, report and follow-up on supplier quality system audits
• Drive supplier quality agreements and coordinate with Procurement, R&D, and Operations
• Own and lead supplier quality projects with limited supervision
• Apply project management to plan and deliver SQM projects
• Analyze quality data to identify trends and drive risk reduction
• Develop/implement Quality Risk Management for supplier matters

Skills

Supplier Quality

Quality Systems

CAPA/NCMR

Project Management

Documentation

Communication

Regulatory Knowledge

Education

Bachelor's in Engineering

Master's in Engineering

Tools

Microsoft Office

Job description

Imperative Care in Campbell, California is seeking a Staff Supplier Quality Engineer to join our on-site, full-time team. You will provide supplier quality engineering support across development, manufacturing, and distribution of our medical devices.

The role emphasizes adherence to ISO 13485 and FDA regulations, supplier audits, change management, CAPA/NCMR, and collaboration with Procurement, R&D, and Operations to prevent disruptions.