Advanced Division Quality Assurance Engineer

Job Summary

The Division Quality Assurance Engineer plays a critical leadership role within Medline product divisions, ensuring that robust quality standards are defined, implemented, and continuously improved across the full product lifecycle—from development through mass production
Key responsibilities include:
1. Lead projects effectively, establish robust quality standards and manage mass production, with final approval authority over product samples, process validation reports, testing results, DMR, NCMR, complaint and change control.
2. Drive the implementation of effective corrective and preventive actions (CAPA) to address customer complaints and adverse quarterly quality trends.
3. Demonstrate strong leadership and communication skills to drive cross-functional collaboration, particularly with US R&D, US PM, US RA, Sourcing, SQE, suppliers, and regional teams across Asia.
4. Ensure full compliance with applicable domestic and international regulations governing product lines and manufacturing processes.

Job Description

CORE JOB RESPONSIBILITIES:

1

Take ownership of project management and product development, collaborating with cross-functional teams (R&D, PM) to define appropriate testing strategies and minimize product failures during new product introduction (NPI).

2

Develop, approve and implement standardized methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure product quality and functionality.

3

Design and execute experimental testing and data analysis to maintain quality performance, minimize defects and failure rates, and drive data-driven decision-making using statistical quality tools.

4

Collaborate with suppliers and key stakeholders (US R&D, US PM, Sourcing, SQE, QE, QC, etc.) to resolve customer complaints, ensure effective implementation of CAPA/SCAR, and drive continuous supplier quality improvement.

5

Ensuring quality decision making, compliance, and final release risk acceptance for both NCMR and Deviation processes.

6

Identify and drive product and process improvement opportunities with suppliers to enhance quality performance and achieve cost efficiencies.

7

Manage and oversee supplier-initiated change requests, ensuring changes are properly evaluated, validated, and implemented in compliance with quality and regulatory requirements

8

Establish and maintain compliant product documentation (e.g., Device Master Records, technical files) and collaborate with Regulatory Affairs and suppliers to support regulatory submissions (e.g., 510(k), Letter to File).

9

Provide expertise in product development, including Design Control, Risk Management, and compliance with applicable technical documentation requirements (e.g., CE Technical Files).

10

Conduct thorough quality reviews of design and development documentation to ensure compliance with internal standards, regulatory requirements, and supplier quality documentation.

11

Drive continuous communication and alignment with suppliers to ensure clear understanding and adherence to internal standards, regulatory requirements, and quality expectations.

12

Coordinate product testing activities with internal and external laboratories to ensure timely and accurate execution of qualification and validation testing.

BASIC QUALIFICATIONS:

Education

Bachelor’s degree in mechanical engineering, Materials Engineering, Industrial Engineering, Medical Devices, or a related engineering discipline

Relevant Work Experience

Minimum 5+ years of engineering experience, preferably with strong project management exposure.

Hands-on experience in process control and quality control is required.

Medical device quality background is preferred.

Additional

-Understanding of quality system requirements (ISO 13485 or ISO 9001).

-Proven ability to read and interpret product specifications, drawings, and technical documentation.

- Demonstrates a professional attitude and a heightened sense of urgency to complete tasks accurately and efficiently.

- Capable of identifying improvement opportunities in products, processes, and documentation, and driving implementation with suppliers and internal teams.

- Strong leadership, collaboration, and influencing skills across cross-functional and cross-regional teams.

- Proficient in engineering and office software tools, including MS Office (Word, Excel), and Adobe tools.

-Experienced in key quality methodologies and tools, such as FMEA, Control plan, MSA, PPAP.

- Willingness to travel frequently (≥30%) as required by project needs

 - Fluent in English (spoken, written, and reading).

- Ability to manage special projects and assignments as directed by manager

PREFERRED QUALIFICATIONS:

Education

Master’s degree in mechanical engineering, Materials Engineering, Industrial Engineering, Medical Devices, or a related engineering discipline, CQE or PMP certification is preferred

Relevant Work Experience

Minimum of 5 years of industry experience in medical devices, pharmaceuticals, or other relevant fields directly related to this role

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 here. 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 pagehere.

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.