Supplier Quality Engineer

Novozen Healthcare LLC; Delaware; On-site; USD 66,000 - 72,000; Full time

Benefits offered by this job

Benefits package

Job summary

Novozen Healthcare LLC in Delaware is seeking an experienced Supplier Quality Engineer to support supplier part qualification and validation activities within a regulated medical device manufacturing environment.

You will lead IQ/OQ/PQ protocols, perform MSA, and collaborate with external suppliers to ensure components meet quality, performance and regulatory requirements. This role requires 5–7 years of relevant experience and strong analytical and documentation skills.

Qualifications

• Bachelor's degree in Engineering is required.
• 5–7 years of professional experience in Supplier Quality Engineering.
• Medical device manufacturing industry experience is mandatory.
• Minimum 3 years hands-on IQ, OQ, PQ, and MSA experience.
• Experience with supplier qualification and quality management systems.

Responsibilities

• Lead supplier part qualification activities, including IQ/OQ/PQ protocols.
• Perform MSA to ensure measurement accuracy and process reliability.
• Collaborate with external suppliers to resolve quality issues and ensure component compliance.
• Review qualification data, identify gaps, and recommend corrective actions.
• Prepare and maintain validation protocols, qualification reports, and quality documentation.
• Work with Engineering, Manufacturing and Quality teams to support supplier qualification and production readiness.
• Ensure qualification activities comply with medical device standards and internal procedures.

Skills

IQ/OQ/PQ

MSA

Supplier qualification

Data analysis

Technical communication

Education

Bachelor's degree in Engineering

Job description

We are seeking an experienced Supplier Quality Engineer to support supplier part qualification and validation activities within a regulated medical device manufacturing environment. The ideal candidate will have strong hands-on experience with IQ/OQ/PQ, Measurement System Analysis (MSA), and supplier quality processes. This role involves working closely with external suppliers and cross-functional teams to ensure components meet quality, performance, and regulatory requirements.

Key Responsibilities

• Lead supplier part qualification activities, including the development and execution of IQ, OQ, and PQ protocols.
• Perform Measurement System Analysis (MSA) to ensure measurement accuracy and process reliability.
• Collaborate with external suppliers to resolve quality issues and ensure component compliance.
• Review qualification data, identify gaps, and recommend corrective actions.
• Prepare and maintain validation protocols, qualification reports, and quality documentation.
• Work closely with Engineering, Manufacturing, and Quality teams to support supplier qualification and production readiness.
• Ensure qualification activities comply with applicable medical device quality standards and internal procedures.

Required Qualifications

• Bachelor's degree in Engineering is required.
• 5–7 years of professional experience in Supplier Quality Engineering or a closely related field.
• Medical device manufacturing industry experience is mandatory.
• Minimum 3 years of hands-on experience with IQ, OQ, PQ, and MSA.
• Strong understanding of supplier qualification, validation, and quality management systems.
• Proven experience working directly with external suppliers on component qualification.
• Ability to independently manage qualification activities with minimal supervision.
• Excellent analytical, technical documentation, communication, and problem-solving skills.

Salary: The hourly rate for this position is 48 -52 per hour. (Depends on experience)

Benefits: Eligible employees may enroll in and receive benefits offered by NovoZen Healthcare LLC, subject to applicable plan terms, eligibility criteria, and contribution requirements.

Equal Employment Opportunity: NovoZen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Background Check: Background checks may be conducted in accordance with applicable law.

Work Authorization: Applicants must be authorized to work in the United States