Quality Engineer - Medical Devices & Supplier Collaboration

Medline Industries, LP; United States; Remote; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Engineer to provide quality perspectives for QA, PM, and Sourcing in the US division. You will verify in-line and finished products, and work with cross-functional teams to set testing parameters to reduce failures.

You will lead supplier quality initiatives, root-cause investigations, and CAPAs to improve quality performance on critical products, while coordinating with US and China teams to minimize rejections and drive cost-effective improvements.

Qualifications

• B.S. Degree in Mechanical Engineering, or Material, or Industrial Engineering or medical device related field.
• 3+ years of engineer experience; project management preferred.
• Understanding of quality system requirements (ISO 13485 or ISO 9001).
• Ability to read and interpret product specifications and drawings.
• Detail oriented with strong written and verbal communication, problem solving, and organizational skills.
• Professional attitude with urgency to complete tasks accurately and efficiently.
• Ability to suggest improvements for finished products, processes and documentation to suppliers, managers, and coworkers.
• Proficiency with AutoCAD or SolidWorks, MS Word, MS Excel, Adobe and Email.
• Willingness to travel frequently.
• Excellent English speaking, reading and writing skills.

Responsibilities

• Ensure suppliers understand Company and International standards for medical devices.
• Perform in-line and finished product verification per standards.
• Collaborate with QA and PM to set testing parameters to limit failures.
• Conduct process audits and identify opportunities for improvement in process and quality control.
• Lead quality-focused projects with vendors, including design changes and CAPA monitoring.
• Assist with root cause investigations and implement CAPAs to reduce complaints.
• Coordinate with US HQ to reduce product rejections and support corrective actions.
• Work with suppliers to identify cost-saving product and process improvements.
• Validate and optimize production parameters and ensure proper documentation.

Skills

Quality mindset

Written & verbal communication

Problem solving

Detail oriented

Ability to travel

Education

Bachelor of Science in Mechanical Engineering or related

Tools

AutoCAD

SolidWorks

MS Word

MS Excel

Adobe

Email

Job description

Medline Industries, LP is seeking a Quality Engineer to provide quality perspectives for QA, PM, and Sourcing in the US division. You will verify in-line and finished products, and work with cross-functional teams to set testing parameters to reduce failures.

You will lead supplier quality initiatives, root-cause investigations, and CAPAs to improve quality performance on critical products, while coordinating with US and China teams to minimize rejections and drive cost-effective improvements.