Senior Supplier Quality Engineer

What you'll do

• Execute supplier process audits and assessments to ensure quality compliance.
• Manage supplier corrective action processes and drive proactive improvements.
• Apply manufacturing quality engineering tools for validation and inspection.
• Lead Quality Engineering deliverables for new product introductions and sustaining projects.
• Provide engineering analyses to ensure regulatory and procedural compliance.
• Develop production controls, including process validation and statistical methods.
• Utilize best practices in team environments for continuous improvement.

What we're looking for

• Bachelor’s degree in engineering with 5+ years of related work experience or Master's degree with 3+ years of experience
• Develop and apply production and process controls, including validation and statistical process control
• Utilize statistical methods for data analysis to drive continuous improvement
• Experience in new product introduction and quality system improvements in a regulated industry
• Lead supplier quality compliance activities and manage supplier relationships
• Certified Lead Auditor with knowledge of FDA/GMP 21CFR820 and ISO 13485 standards
• Background in injection molding and electro-mechanical systems engineering