Supplier Quality Engineer

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

We are 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.

Key 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.

Required 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.

Salary:

The hourly rate for this position is $44–$52 per hour.

Benefits:

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable law.

Work Authorization:

Applicants must be authorized to work in the United States.