Sr. Supplier Quality Engineer

Senior Supplier Quality Engineer (Sr. SQE)

Location:
On-site / Hybrid

Employment Type:
Full-time

We are seeking an experienced
Senior Supplier Quality Engineer (Sr. SQE)
to ensure the quality, compliance, and reliability of supplied materials, components, and services supporting
Class III medical devices
. This role partners closely with internal cross-functional teams and external suppliers to build robust supplier quality systems, conduct audits, drive continuous improvement, and maintain compliance with global regulatory requirements.

Key Responsibilities

• Lead qualification, approval, and ongoing performance monitoring of critical suppliers, contract manufacturers, and service providers
• Plan and conduct supplier audits (on-site and remote) aligned with FDA QMSR, ISO 13485, and EU MDR requirements
• Own supplier nonconformances and SCARs, ensuring timely investigation, root cause analysis, and effective corrective actions
• Develop, negotiate, and maintain supplier quality agreements in collaboration with Legal and Procurement
• Partner with R&D, Manufacturing, and Regulatory teams to assess and approve supplier-related changes (e.g., change control, validations)
• Ensure supplier documentation and processes meet design control, regulatory, and product-specific requirements
• Support incoming inspection strategies and sampling plans (AQL, ANSI, risk-based approaches)
• Lead supplier quality risk assessments and contribute to risk management files per ISO 14971
• Support supplier onboarding, training, and continuous improvement initiatives
• Provide supplier-related documentation and data for regulatory submissions and inspections
• Track supplier quality KPIs and lead improvement initiatives based on performance trends

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• 5–7+ years of supplier quality engineering experience in a medical device environment (Class II or III preferred)
• Strong working knowledge of:
• FDA 21 CFR Part 820 / QMSR
• ISO 13485
• EU MDR
• ISO 14971
• Experience managing supplier audits, SCARs, and quality agreements
• Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or equivalent certification preferred
• Lead Auditor certification or significant supplier audit experience
• Experience working with international suppliers and global regulatory requirements
• Working knowledge of statistical tools and analysis (e.g., Minitab, JMP)
• Familiarity with materials and components used in implantable medical devices preferred
• Experience with ERP systems (e.g., SAP, D365) and electronic QMS platforms (e.g., TrackWise, MasterControl)
• Excellent communication, analytical, and problem-solving skills

Job Requirement

• Must be legally authorized to work in the United States