Medical Device Supplier Quality Engineer (Contract)

Novozen Healthcare LLC; Newark (DE); On-site; USD 61,000 - 72,000; Full time

Job summary

Novozen Healthcare LLC is seeking a hands-on Supplier Quality Engineer to support supplier parts qualification within a medical device manufacturing environment. The ideal candidate will have strong experience with qualification, validation, measurement systems, and working directly with external suppliers.

The role requires leading qualification activities, coordinating IQ/OQ/PQ/MSA processes, and ensuring compliance with medical device quality requirements.

Qualifications

• 5–7 years of Supplier Quality Engineering or closely 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

IQ/OQ/PQ

MSA experience

Supplier quality

Analytical skills

Communication skills

Problem solving

Job description

Novozen Healthcare LLC is seeking a hands-on Supplier Quality Engineer to support supplier parts qualification within a medical device manufacturing environment. The ideal candidate will have strong experience with qualification, validation, measurement systems, and working directly with external suppliers.

The role requires leading qualification activities, coordinating IQ/OQ/PQ/MSA processes, and ensuring compliance with medical device quality requirements.