Senior Engineer, Supplier Management
Job Description:
• Lead Medline’s supplier quality oversight for a global supply base
• Own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers
• Drive cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance
• Lead risk‑based supplier oversight across regions; set audit/monitoring depth by risk tier and product classification
• Lead communication efforts related to high-risk suppliers with internal stakeholders
• Own complex supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments
• Author and maintain supplier quality agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements
• Analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance
• Work with quality support groups to proactively identify issues and lead the containment of them
• Provide technical guidance and training to suppliers on quality standards and best practices
• Troubleshoot in-depth vendor issues that impact multiple business units to improve the global supply chain and improve supplier processes
• Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem‑solving methods
• Maintain accurate records of audits, performance reviews, and compliance reports
• Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements
Requirements:
• Bachelor’s degree in Engineering, Biology, Quality Management, or related field
• 6-8 years in supplier quality, manufacturing quality, or similar role
• in-depth knowledge of ISO standards and FDA regulations
• strong communication, problem-solving, and negotiation skills
• ownership of CAPA or SCAR throughout its lifecycle
• strong Medical Device or Drug regulatory experience
• strong critical thinking abilities
• experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP)
Benefits:
• health insurance
• life and disability
• 401(k) contributions
• paid time off
• access to the Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp
Apply tot his job
Apply To this Job
• Lead Medline’s supplier quality oversight for a global supply base
• Own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers
• Drive cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance
• Lead risk‑based supplier oversight across regions; set audit/monitoring depth by risk tier and product classification
• Lead communication efforts related to high-risk suppliers with internal stakeholders
• Own complex supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments
• Author and maintain supplier quality agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements
• Analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance
• Work with quality support groups to proactively identify issues and lead the containment of them
• Provide technical guidance and training to suppliers on quality standards and best practices
• Troubleshoot in-depth vendor issues that impact multiple business units to improve the global supply chain and improve supplier processes
• Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem‑solving methods
• Maintain accurate records of audits, performance reviews, and compliance reports
• Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements
Requirements:
• Bachelor’s degree in Engineering, Biology, Quality Management, or related field
• 6-8 years in supplier quality, manufacturing quality, or similar role
• in-depth knowledge of ISO standards and FDA regulations
• strong communication, problem-solving, and negotiation skills
• ownership of CAPA or SCAR throughout its lifecycle
• strong Medical Device or Drug regulatory experience
• strong critical thinking abilities
• experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP)
Benefits:
• health insurance
• life and disability
• 401(k) contributions
• paid time off
• access to the Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp
Apply tot his job
Apply To this Job