Senior Manager, Supplier Quality & 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) plan

Health benefits

Paid time off

Parental leave

Job summary

Imperative Care is seeking a Senior Supplier Quality Manager to lead the Supplier Quality Engineering and Contract Manufacturing Quality groups. You will ensure compliance with ISO 13485, FDA regulations, and governing standards while directing supplier collaboration and auditable processes.

The role requires 8+ years in supplier quality within medical devices, supervisory experience, and strong documentation/communication skills.

Qualifications

• BS in Engineering or related discipline with 8+ years in supplier quality, or MS with 6+ years in medical device or regulated industry.
• 2+ years supervisory experience strongly preferred.
• Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.).
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP.
• Excellent written and verbal communication skills; ability to produce clear technical docs.
• Lead auditor certification a plus.

Responsibilities

• Lead and manage Supplier Quality Engineering and Contract Manufacturing Quality in support of manufacturing, development, and distribution of medical devices.
• Direct collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.
• Oversee staffing, mentoring, and development of the supplier quality team.
• Drive improvements in supplier quality through metrics, audits, and CAPA management.
• Investigate supplier-related issues with timely resolution/prevention to minimize disruptions.
• Monitor SCARs and drive resolution and risk control processes.
• Oversee supplier audits/requalification and incoming inspection criteria for subassemblies.
• Promote regulatory compliance and support internal/external audits.
• Present supplier-related issues or opportunities to senior management.
• Lead projects applying PM methodologies to SQM initiatives.

Skills

Supplier Quality Management

Quality System Compliance

CAPAs NCRs SCARs

Audits

Project Management

Risk Management

Communication

Lead Auditor

Education

Bachelor's in Engineering

MS in Engineering (optional)

Tools

None

Job description

Imperative Care is seeking a Senior Supplier Quality Manager to lead the Supplier Quality Engineering and Contract Manufacturing Quality groups. You will ensure compliance with ISO 13485, FDA regulations, and governing standards while directing supplier collaboration and auditable processes.

The role requires 8+ years in supplier quality within medical devices, supervisory experience, and strong documentation/communication skills.