Supplier Quality Engineer

Qualifications

• BA/BS in Engineering or equivalent experience in medical device manufacturing supplier controls (2+ years) or 4+ years without degree.
• Preferred: ASQ Certified Quality Engineer.
• Preferred: Certified Auditor with auditing experience.
• Strong knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 standards.
• Proficient in leading CAPA investigations and supplier corrective actions.
• Strong MS Office Suite skills for documentation and analysis.

Responsibilities

• Execute quality maintenance and improvement activities for purchased part qualification.
• Drive supplier development through quality audits and technical guidance.
• Manage investigations of non-conforming materials and implement corrective actions.
• Assist in validation processes for supplier outputs and maintain quality records.
• Monitor and report on supplier-related quality metrics.

Benefits

• Competitive compensation package including bonus and equity options.
• Potential for career advancement within the company.
• Comprehensive benefits package to support employee well-being.
• Dynamic workplace culture focused on engagement and evolution.