Staff Supplier Quality Engineer — Medical Devices

Imperative Care; Kentucky; 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 seeks a Staff Supplier Quality Engineer to join our on-site team in Campbell, CA. You will provide supplier quality engineering support for medical devices, ensuring compliance with ISO 13485 and FDA requirements.

The role involves leading supplier change management, CAPA, NCMR, audits, and cross-functional collaboration. The ideal candidate has a strong background in supplier quality within regulated medical devices, experience with catheters or neurovascular products, and

Qualifications

• B.S. in Engineering or related discipline with 8+ years of supplier quality experience; or M.S. in Engineering with 6+ years of related experience.
• Experience with FDA 21 CFR Part 820, ISO 13485, ISO 14971 and GMP practices.
• Experience with catheters, endovascular or neurological devices.

Responsibilities

• Provide SQE support in development, manufacture and distribution of medical devices.
• Establish and maintain quality assurance standards per ISO 13485 and FDA regulations.
• Lead supplier change management, CAPA, NCMR, and supplier audits.
• Drive supplier quality improvements and risk management with cross-functional teams.
• Collaborate with Procurement, R&D, Operations to resolve supplier-related issues.

Skills

Supplier quality management

Multitasking

Analytical problem solving

Documentation review

Effective communication

Education

B.S. in Engineering

M.S. in Engineering (optional)

Tools

Microsoft Office

Job description

Imperative Care seeks a Staff Supplier Quality Engineer to join our on-site team in Campbell, CA. You will provide supplier quality engineering support for medical devices, ensuring compliance with ISO 13485 and FDA requirements.

The role involves leading supplier change management, CAPA, NCMR, audits, and cross-functional collaboration. The ideal candidate has a strong background in supplier quality within regulated medical devices, experience with catheters or neurovascular products, and