The Davis Companies
This range is provided by The Davis Companies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $100,000.00/yr - $130,000.00/yr
Additional compensation types
Annual Bonus
Title 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
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Disability insurance
Referrals increase your chances of interviewing at The Davis Companies by 2x
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Base pay range $100,000.00/yr - $130,000.00/yr
Additional compensation types
Annual Bonus
Title 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
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Disability insurance
Referrals increase your chances of interviewing at The Davis Companies by 2x
#J-18808-Ljbffr