Senior Supplier Quality Engineer - Medical Device, On-Site

Imperative Care; Campbell (AK); 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, based in Campbell, CA, is seeking a Staff Supplier Quality Engineer to join our on-site team. The role focuses on collaborating with suppliers to ensure robust materials, processes and systems, leading supplier qualification changes, and driving CAPA and risk management activities.

The candidate will manage supplier performance metrics, conduct audits, and lead supplier quality initiatives to minimize risks and support product quality.

Qualifications

• 8+ years supplier quality experience in medical devices or regulated industry
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485 and ISO 14971
• Excellent written and verbal communication skills
• Proven ability to lead CAPA/NCMR/SCAR and supplier-related issues

Responsibilities

• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Lead supplier quality improvement initiatives and change management activities.
• Manage supplier performance metrics and drive corrective actions for quality issues.
• Plan and conduct supplier quality system audits and drive risk management for supplier matters.
• Present supplier-related issues or opportunities to management

Education

Bachelor's or Master's in Engineering

8+ years supplier quality experience

Job description

Imperative Care, based in Campbell, CA, is seeking a Staff Supplier Quality Engineer to join our on-site team. The role focuses on collaborating with suppliers to ensure robust materials, processes and systems, leading supplier qualification changes, and driving CAPA and risk management activities.

The candidate will manage supplier performance metrics, conduct audits, and lead supplier quality initiatives to minimize risks and support product quality.