HR Advisor
medline
Principal Engineer Quality
medline· Medline Industries, LP (Shanghai) Ltd.
About this role
Job Summary
Job Description
Job Responsibilities
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•Act as site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems (PW/WFI, distribution loops), filling systems (aseptic and non-aseptic), cleaning processes (CIP/COP, manual cleaning validation), and injection molding processes.
•Define critical process parameters (CPPs) and critical quality attributes (CQAs) for complex manufacturing processes using risk-based approaches.
•Draft, review, approve and finalize IQ , OQ , PQ protocols and validation reports for medical device production equipment, testing equipment and facility utilities.
•Lead and oversee on-site validation execution, verify test data integrity, accuracy and traceability.
•Draft, review and optimize validation SOPs, validation master plans and related validation database.
•Manage validation deviations, non-conformances and change controls; drive corrective actions and closure.
•Support internal/external audit, customer audit and regulatory inspection with complete validation documentation.
•Conduct technical communication and coordination with engineering, production, R&D and cross-functional teams on validation matters.
•Ensure all validation activities comply with ISO 13485, FDA QSR 21 CFR 820, MDR and local medical device GMP requirements.
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Job Requirements
•Bachelor degree or above in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Quality Management, Pharmaceutical Engineering or related majors.
•Minimum 7+ years working experience in medical device industry with solid IQ/OQ/PQ validation experience.
•Familiar with ISO 13485, medical device GMP, FDA 21 CFR 820 and EU MDR regulatory requirements; Familiar with Statistic technology and application, especially sampling method
•Proficient in writing, reviewing and approving IQ/OQ/PQ protocols and validation reports independently.
•Good understanding of medical device production process, equipment validation, cleanroom and utility system qualification.
•Strong English reading and writing ability, able to understand and prepare English validation documents.
•Rigorous, detail-oriented, good communication, problem-solving and cross-team coordination skills.
•Travel to both Medline facilities and vendor sites approximately 30%. (Potential international travel)
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 page here.
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.
Frequently Asked Questions
Is the salary disclosed for the Principal Engineer Quality position at medline?
The salary for this Principal Engineer Quality role at medline is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Principal Engineer Quality position at medline located?
This Principal Engineer Quality role at medline is based in Shanghai 上海. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Principal Engineer Quality role at medline full-time or part-time?
This is listed as a Full time position. It is posted as a Principal Engineer Quality role in the Medline Industries, LP (Shanghai) Ltd. department at medline.
Which team or department does the Principal Engineer Quality at medline belong to?
This Principal Engineer Quality position is part of the Medline Industries, LP (Shanghai) Ltd. department at medline. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Principal Engineer Quality position at medline?
Click the "Apply Now" button on this page. You will be redirected to medline's official application portal hosted on workday where you can submit your application directly.
When was the Principal Engineer Quality job at medline posted?
This Principal Engineer Quality position at medline was posted on Jul 23, 2026. Apply as soon as possible — early applications are often reviewed first.
Principal Engineer Quality
medline
You'll be redirected to medline's official application page on Workday.