Engineer QA

Job Summary

The Quality Assurance Engineer plays a critical role in supporting various divisions within Medline by providing quality-related recommendations and insights. This role involves collaborating with departments such as Quality Assurance, Project Management, and Sourcing to ensure the successful completion of assigned projects.

Key Responsibilities

• Communicate clearly with suppliers regarding Company and International standards, processes, and protocols related to medical devices.
• Conduct in-line and finished product verifications to maintain compliance with Company and International quality standards.
• Coordinate with teams like QA and Project Management to establish effective testing parameters that minimize product failures.
• Perform process audits, identifying areas for ongoing improvements in process control, production control, and quality assurance.
• Oversee quality-related aspects of vendor projects, focusing on product design changes, quality enhancement initiatives, and monitoring performance of critical products.
• Collaborate with suppliers and the Company's US corporate office to resolve customer complaints, specifically by conducting root cause analyses and implementing corrective actions to reduce complaint occurrences.
• Partner with suppliers and the QC team in China to decrease product rejection rates.
• Identify opportunities with suppliers for product and process improvements that yield cost savings.
• Validate and optimize production parameters in cooperation with suppliers, ensuring proper documentation and verification once implemented.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, Industrial Engineering, Medical Device Engineering, or related fields.
• Minimum three years of engineering experience; project management experience preferred.
• Strong expertise in process control and quality control methodologies.
• Familiarity with quality system standards such as ISO 13485 or ISO 9001.
• Ability to interpret product specifications and technical drawings accurately.
• Detail-oriented with excellent communication skills, problem-solving abilities, and organizational capabilities.
• Professional demeanor with a strong sense of urgency to complete tasks efficiently and accurately.
• Proactive in identifying and recommending enhancements for products, processes, and documentation to suppliers and internal teams.
• Proficient with PC software including AutoCAD or SolidWorks, Microsoft Word, Excel, Adobe, and email.
• Willingness to travel frequently as part of job responsibilities.
• Fluency in English communication – spoken, read, and written.
• Ability to manage special projects as delegated by management.

Additional Information

Medline offers a comprehensive benefits package including health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working 30 or more hours per week. Employees with fewer hours have access to 401(k), Employee Assistance Program, Resource Groups, and the Employee Service Corp.

The company promotes an inclusive culture valuing diversity across all characteristics protected by law. It is an equal opportunity employer committed to ensuring each individual feels they belong and can flourish professionally.