Sr Engineer Supplier Quality
Medline Industries - Transportation & Operations
Springfield, IL
Job Summary
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.Job Description
MAJOR 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
MINIMUM JOB REQUIREMENTS
Education
Bachelor’s degree in Engineering, Biology, Quality Management, or related field
Certification / Licensure
Work Experience
6-8 years in supplier quality, manufacturing quality, or similar role
Knowledge / Skills / Abilities
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)
PREFERRED JOB REQUIREMENTS
Education
Masters of Biology, Chemistry, Engineering, Quality Management, or similar field
Certification / Licensure
ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional
Six Sigma Green Belt or higher
Work Experience
Front or backroom FDA or ISO audit experience
Supplier quality auditing
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$116,000.00 - $174,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click
. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page
.Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.