Job Summary
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; 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. Drive 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.

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 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).

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:
$101,000.00 - $152,000.00 Annual

The 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

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 here.