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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.
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.
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.
Bachelor's degree in Engineering.
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.
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.
Applicants must be authorized to work in the United States.