Quality Engineer

Job title: Quality Engineer

About the Role Quality engineer is an essential support role for a division at Medline. He/She will provide suggestions or comments from a quality perspective to contribute to the completion of assigned projects in collaboration with QA, PM, or Sourcing.

What You'll Do

• Ensure suppliers are clear on Company and International standards, processes and procedures related to various medical devices.
• Perform in-line and finished product verification to ensure acceptable quality.
• Work with QA and PM to determine appropriate testing parameters to minimize product failures.
• Conduct process audits and identify opportunities for continuous improvement on process control, production control and quality control.
• Lead projects with vendors from a quality perspective (product design changes, quality performance improvements, and monitoring quality performance on critical products).
• Collaborate with Suppliers and US corporate office to resolve customer complaints, including root cause investigations and CAPA implementation to reduce complaint numbers.
• Ensure solutions to quality issues are properly implemented and sustained.
• Work with suppliers and QC team in China to reduce product rejections.
• Identify opportunities for product and process improvements that lead to cost savings.
• Validate and optimize production parameters with suppliers and ensure proper documentation and verification of these parameters.

What We're Looking For

• B.S. degree in Mechanical Engineering, Materials, Industrial Engineering, or Medical Device related engineering field.
• 3+ years of engineering experience; project management preferred.
• On process control and quality control is required.
• 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 a heightened sense of urgency to complete tasks accurately and efficiently.
• Ability to recognize and suggest improvements for finished products, processes, and documentation practices to suppliers, managers, and coworkers.
• Proficiency with AutoCAD or SolidWorks, MS Word, MS Excel, Adobe, and E-mail.
• Available to travel frequently.
• Excellent English speaking, reading and writing skills.
• Capable of handling special projects as directed by Managers.

Nice to Have

• Experience with CAPAs and root cause investigations.
• Familiarity with medical device regulatory requirements.
• Travel readiness.

Compensation & Benefits

• Health insurance, life and disability, 401(k) contributions, paid time off for employees working 30 or more hours per week.
• For roles with 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.
• Medline is an equal opportunity employer and supports a culture of belonging.