Onsite Supplier Quality Engineer - Medical Devices (Contract)

Intellectt INC; Newark (DE); On-site; USD 61,000 - 68,000; Full time

Job summary

Intellectt INC is seeking a hands-on Supplier Quality Engineer to support supplier parts qualification in a medical device manufacturing environment. You will lead qualification activities, develop protocols, and coordinate with suppliers to ensure regulatory and quality compliance.

Key duties include IQ, OQ, PQ, and MSA execution, data review, and collaboration with Quality, Engineering, and Manufacturing teams to resolve issues and document results.

Qualifications

• Bachelor's degree in Engineering.
• 5–7 years of Supplier Quality Engineering or related experience.
• Medical device industry experience.
• 3+ years of hands-on IQ, OQ, PQ, and MSA experience.
• Strong knowledge of supplier qualification, validation, and quality systems.
• Experience working directly with external suppliers.
• Strong analytical, communication, and problem-solving skills.
• Ability to independently manage qualification activities with limited direction.

Responsibilities

• Lead and support supplier part/component qualification activities.
• Develop, execute, and review qualification protocols and documentation.
• Perform and support IQ, OQ, PQ, and MSA activities.
• Work directly with suppliers to resolve qualification and quality issues.
• Review qualification data and identify gaps or nonconformances.
• Collaborate with Quality, Engineering, Manufacturing, and cross-functional teams.
• Ensure supplier qualification activities meet medical device quality requirements.
• Document qualification results, findings, and recommendations.

Skills

Supplier Quality Engineering

Qualification protocols

Measurement systems

External supplier collaboration

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ/MSA processes

Job description

Intellectt INC is seeking a hands-on Supplier Quality Engineer to support supplier parts qualification in a medical device manufacturing environment. You will lead qualification activities, develop protocols, and coordinate with suppliers to ensure regulatory and quality compliance.

Key duties include IQ, OQ, PQ, and MSA execution, data review, and collaboration with Quality, Engineering, and Manufacturing teams to resolve issues and document results.