Specific SQE for Parts/Components Qualification

Creative Solutions Services, LLC; Newark (DE); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Supplier Quality Engineer to support supplier parts qualification. You will develop and review qualification protocols, perform IQ/OQ/PQ/MSA activities, and work with suppliers and cross-functional teams to resolve quality issues.

Requirements include a Bachelor's degree in Engineering, 5–7 years of engineering experience, and 3+ years in IQ/OQ/PQ/MSA with supplier qualification and medical device exposure. Remediation experience is not required.

Qualifications

• Bachelor's degree in Engineering required.
• 5–7 years of engineering experience.
• 3+ years of IQ/OQ/PQ/MSA experience.
• Experience with supplier parts qualification.
• Medical device experience.
• Remediation experience not required.

Responsibilities

• Support supplier part qualification activities.
• Develop, execute, and review qualification protocols and documentation.
• Perform IQ, OQ, PQ, and MSA activities.
• Work with suppliers and cross-functional teams to resolve quality and qualification issues.
• Review qualification data and ensure compliance with quality requirements.

Skills

Quality assurance

IQ/OQ/PQ/MSA

Supplier qualification

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering

Job description

Job Description:

Our client, a leading women's health medical device company, is seeking Supplier Quality Engineers to support supplier parts qualification.

Responsibilities:

• Support supplier part/component qualification activities.
• Develop, execute, and review qualification protocols and documentation.
• Perform/support IQ, OQ, PQ, and MSA activities.
• Work with suppliers and cross-functional teams to resolve quality and qualification issues.
• Review qualification data and ensure compliance with quality requirements.

Requirements:

• Bachelor's degree in Engineering required.
• 5–7 years of engineering experience.
• 3+ years of experience with IQ, OQ, PQ, and MSA required.
• Experience with supplier parts/component qualification.
• Medical device experience.
• Remediation experience is not required.