Advanced Engineer DQA

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