Senior Engineer, Supplier Management

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Oversee Medline’s supplier quality management for a worldwide supply network.

• Manage risk-based qualifications, performance assessments, scorecards, and audit implementations for high-risk suppliers.

• Facilitate cross-functional corrective and preventive actions along with supplier development to enhance quality, reliability, and compliance.

• Direct risk-based supplier monitoring across various regions; establish audit and monitoring depth based on risk tier and product classification.

• Lead communication initiatives concerning high-risk suppliers with internal stakeholders.

• Handle complex supplier qualifications and disqualifications for critical suppliers, which includes reviewing technical documentation and conducting potential on-site evaluations.

• Create and update supplier quality agreements and inspection plans in collaboration with Procurement/Legal; ensure compliance with device regulations and regional mandates.

• Analyze trends and drive SCAR/CAPA to ensure effectiveness; escalate issues according to governance protocols.

• Collaborate with quality support groups to proactively identify problems and lead their containment.

• Offer technical guidance and training to suppliers on quality standards and best practices.

• Resolve complex vendor issues affecting multiple business units to enhance the global supply chain and refine supplier processes.

• Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem-solving techniques.

• Keep detailed records of audits, performance evaluations, and compliance documentation.

• Assist or conduct audits of high-risk suppliers in accordance with ISO 13485, ISO 9001, and/or relevant regulatory requirements.

⛳️ Requirements

• Bachelor’s degree in Engineering, Biology, Quality Management, or a related field.

• 6-8 years of experience in supplier quality, manufacturing quality, or a comparable role.

• Comprehensive knowledge of ISO standards and FDA regulations.

• Excellent communication, problem-solving, and negotiation abilities.

• Proven ownership of CAPA or SCAR throughout its entire lifecycle.

• Strong background in Medical Device or Drug regulatory affairs.

• Exceptional critical thinking skills.

• Familiarity with statistical process control (SPC) and quality tools (FMEA, PPAP, APQP).

🏝️ Benefits

• Health insurance.

• Life and disability coverage.

• 401(k) contributions.

• Paid time off.

• Access to the Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.