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The Davis Companies · 4 weeks ago

Sr. Supplier Quality Engineer

Union County, NJ

Full-time

Onsite

Senior Level

$100K/yr - $130K/yr

5+ years exp

The Davis Companies is looking for an experienced Senior Supplier Quality Engineer to ensure the quality, compliance, and reliability of supplied materials and services for Class III medical devices. This role involves partnering with cross-functional teams and suppliers to build robust quality systems, conduct audits, and maintain regulatory compliance.

Property ManagementReal Estate

Growth Opportunities

Hiring Manager

Rich Gardner PHR

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

Qualification

Supplier Quality EngineeringFDA 21 CFR Part 820ISO 13485EU MDRCertified Quality EngineerLead Auditor certificationStatistical toolsERP systemsAnalytical skillsCommunicationProblem-solving skills

Required

Bachelor's degree in Engineering, Life Sciences, or a related technical field

Strong working knowledge of: FDA 21 CFR Part 820 / QMSR

Strong working knowledge of: ISO 13485

Strong working knowledge of: EU MDR

Strong working knowledge of: ISO 14971

Experience managing supplier audits, SCARs, and quality agreements

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)

Experience with ERP systems (e.g., SAP, D365) and electronic QMS platforms (e.g., TrackWise, MasterControl)

Excellent communication, analytical, and problem-solving skills

Must be legally authorized to work in the United States

Preferred

5–7+ years of supplier quality engineering experience in a medical device environment (Class II or III preferred)

Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or equivalent certification preferred

Familiarity with materials and components used in implantable medical devices preferred

Company

The Davis Companies

The DAVIS Companies is a preferred source for Staffing Solutions and Talent Advisory Services, specializing in contract, contract-to-hire and direct hire staffing for Engineering, Skilled Manufacturing, IT and Software personnel.

Founded in 1985

Boston, Massachusetts, USA

51-200 employees