Senior Leader, Supplier Quality Engineering & Compliance

Imperative Care; Campbell (CA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Stock options

Bonus opportunities

401(k)

Health benefits

Generous paid time off

Parental leave

Job summary

Imperative Care in Campbell, CA seeks a Senior Manager to lead the Supplier Quality Engineering group and Contract Manufacturing Quality for medical device products. You will establish QA standards aligned with ISO 13485, FDA, and regulations, and drive supplier performance, audits, and SCAR resolution.

You will manage staff, partner with Procurement, R&D, Operations, and Suppliers to prevent disruptions, improve quality metrics, and ensure regulatory compliance across supplier quality systems.

Qualifications

• 8+ years in supplier quality within medical devices or regulated industries.
• Experience leading supplier or process issues (CAPAs, NCRs, SCARs).
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Excellent written and verbal communication skills.

Responsibilities

• Lead the Supplier Quality Engineering group and contract manufacturing quality activities.
• Direct collaboration with suppliers/CMs/OEMs to ensure robust materials and processes.
• Oversee supplier audits, qualification, and SCAR management.
• Mentor and develop staff, manage day-to-day resourcing and growth.
• Drive continuous improvement and risk management across supplier quality systems.

Skills

Supplier Quality

CAPA Management

NCR Handling

SCARs

Regulatory Compliance

Leadership

Communication

Education

BS in Engineering

MS in Engineering

Tools

Audit Tools

Job description

Imperative Care in Campbell, CA seeks a Senior Manager to lead the Supplier Quality Engineering group and Contract Manufacturing Quality for medical device products. You will establish QA standards aligned with ISO 13485, FDA, and regulations, and drive supplier performance, audits, and SCAR resolution.

You will manage staff, partner with Procurement, R&D, Operations, and Suppliers to prevent disruptions, improve quality metrics, and ensure regulatory compliance across supplier quality systems.