Sr Engineer Supplier Quality

Medline Industries, LP

1d•$116,000 - $174,000

About The Position

The Sr Engineer Supplier Quality will lead Medline’s supplier quality oversight for a global supply base. They will own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers; act as SME on purchasing controls (21 CFR 820 §820.50 and ISO 13485:2016 7.4) and represent Supplier Quality during internal/external inspections. The Sr Engineer drives cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance.

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 it’s lifecycle
Strong Medical Device or Drug regulatory experience
Strong critical thinking abilities
Experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP)
Travel up to 25% (domestic and/or international)

Nice To Haves

Masters of Biology, Chemistry, Engineering, Quality Management, or similar field
ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional
Six Sigma Green Belt or higher
Front or backroom FDA or ISO audit experience
Supplier quality auditing

Responsibilities

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
Own the supplier scorecard program for assigned categories; analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance
Work with quality support groups (ex. Risk Management, Design and Development, Post-Market Surveillance, etc) to proactively identify issues and lead the containment of them
Lead partnership with procurement, engineering, and operations teams to resolve supplier-related quality issues
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
Oversees scorecard program and executive quality metric dashboards
Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements