Supplier Quality Engineer (medical device)

Intellectt Inc; Delaware; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is looking for a Supplier Quality Engineer to ensure compliance and quality in the supply chain for Class II/III devices. Responsibilities include leading supplier qualifications, conducting process validations, and performing on-site audits. The ideal candidate should have experience in FDA regulations and a background in continuous improvement using Lean/Six Sigma. This position demands strong analytical skills, technical support abilities, and effective communication across departments.

Qualifications

• Experience in supporting supplier qualification for medical devices.
• Familiarity with FDA QSR 21 CFR Part 820 and ISO 13485.
• Ability to conduct supplier audits and risk assessments.

Responsibilities

• Lead supplier part qualification for product launches.
• Execute supplier process validations and capability studies.
• Provide technical support for inspections and audits.

Skills

Supplier qualification

Process validation

Statistical analysis

Lean/Six Sigma techniques

Job description

Supplier Quality Engineer – Medical Device

Location: Delaware (Onsite)

Duration: 12-Month Contract

We are seeking a Supplier Quality Engineer to support supplier qualification, process validation, and ongoing supplier performance for complex Class II/III medical devices. This role works cross-functionally with R&D, Design Assurance, Regulatory, Operations, and Supplier Engineering to ensure quality and compliance throughout the supply chain.

Key Responsibilities

• Lead supplier part qualification to support development and commercial launch schedules
• Execute supplier process validations (IQ/OQ/PQ) and capability studies
• Conduct GR&R studies, SPC monitoring, and statistical analysis
• Develop test methods, inspection plans, and measurement fixtures
• Support creation and revision of component specifications, print reviews, and GD&T interpretation
• Analyze and disposition supplier nonconformances
• Lead root cause investigations and drive corrective/preventive actions (CAPAs/SCARs)
• Provide technical support to Receiving Inspection and manufacturing
• Plan, schedule, and perform on-site supplier audits (process, QMS, special process)
• Assess supplier compliance to FDA QSR 21 CFR Part 820, ISO 13485, ISO 9001
• Prepare audit reports, identify gaps, and verify corrective action implementation
• Evaluate supplier risk level and maintain approved supplier records
• Conduct supplier monitoring and re-evaluation audits as required
• Support PFMEA, process control plans, and supplier quality agreements
• Monitor supplier performance metrics and present risks to leadership
• Identify and execute continuous improvement projects using Lean/Six Sigma techniques