Sr. Supplier Quality Engineer

Description

About us: For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary

The Senior Supplier Quality Engineer is responsible for ensuring the quality, compliance, and performance of external suppliers through the evaluation and oversight of manufacturing processes and quality systems. This role conducts supplier assessments and audits, supports supplier selection and qualification activities, monitors supplier performance, and drives corrective and preventive actions to ensure products meet company, customer, and regulatory requirements. The Senior Supplier Quality Engineer partners closely with suppliers and cross-functional teams to identify risks, implement improvements, and maintain a reliable and compliant supply chain.

Key Responsibilities

• Tracks supplier responses and conducts follow-up activities, including escalation when necessary.
• Reviews existing Quality Agreements, determines when revisions are needed, and coordinates updates with suppliers.
• Collections, analyzes, and monitors supplier quality and performance data from internal sources.
• Prepares, maintains, and submits required quality records and documentation for closure and filing.
• Develops and manages supplied product inspection procedures, including first article inspection requirements.
• Evaluates supplier capabilities through on-site assessments, technical discussions, directed testing, and quality system audits.
• Communicates supplier quality issues proactively through audits, supplier corrective action requests (SCARs), and technical discussions.
• Participates in and provides engineering ownership for supplier-related Non-Conforming Material Reviews (NCMRs).

Mandatory Qualifications

• Bachelor's degree in a STEM-related engineering discipline required.
• Minimum of 5 years of relevant engineering experience required.
• Experience working in an engineering environment with mechanical systems, tooling design, and manufacturing processes; medical device industry experience preferred.
• Progressive experience in Supplier Quality Engineering, preferably within the medical device industry.
• Working knowledge and experience with Corrective and Preventive Actions (CAPA), process validation, design controls, and risk management methodologies.

Salary Range

$115,000-140,000

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match