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Job Description

Insight Global is looking for a Supplier Quality Engineer. The Supplier Quality Engineer is responsible for conducting and assisting with supplier audits, preparing audit reports, and managing corrective actions. They maintain and qualify new suppliers for the Approved Supplier List (ASL), evaluate purchase requests, and negotiate Supplier Quality Agreements. The role includes managing supplier scorecards, monitoring performance, and leading process validation activities. They coordinate first article inspections, develop inspection procedures, and validate test methods. The engineer resolves quality issues, manages document control, and trains quality inspectors and junior staff. They handle nonconforming products, implement corrective actions, and collaborate with suppliers on quality issues and process risk management. Additionally, they review supplier change requests and participate in supplier-based R&D projects.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Skills and Requirements

A Bachelors Degree or Higher in an engineering or scientific discipline.

Minimum four (4) years experience in a Supplier Quality Engineering role or other engineering role in the medical device industry.

Experience in verification and validation activities including component qualifications and capability

Experience with supplier auditing

Experience with design controls as it pertains to supplier and partner projects

Experience with metric reporting

Proficiency required with word processing, spreadsheet and document management software. Certified ISO 13485 Lead Auditor

Knowledge of ISO 14971 for risk management of medical devices.

Proficiency desired with application of statistical techniques for manufacturing and quality systems.

Knowledge or LEAN manufacturing principles. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].