What are the responsibilities and job description for the Sr. Supplier Quality Engineer position at The Davis Companies?
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