Principal Engineer Quality

Medline; Shanghai (VA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline seeks a senior Validation expert to act as site SME for validation across equipment, sterile packaging, water systems and injection molding processes. You will define CPPs/CQAs, draft IQ/OQ/PQ protocols and validation reports, and oversee on-site validation with data integrity and traceability.

Expect extensive collaboration with engineering, production and R&D to ensure regulatory compliance.

Qualifications

• Bachelor’s degree or higher in a relevant engineering/quality field.
• Minimum 7+ years of validation experience in medical device industry.
• Familiar with ISO 13485, regulatory requirements (FDA 21 CFR 820, EU MDR).
• Proficient in writing and reviewing IQ/OQ/PQ protocols and validation reports.

Responsibilities

• Act as site SME for validation of equipment, sterile packaging, and processes.
• Define CPPs and CQAs for complex manufacturing processes using risk-based approaches.
• Draft, review, approve IQ, OQ, PQ protocols and validation reports.
• Lead on-site validation execution and verify data integrity and traceability.
• Draft and optimize validation SOPs, master plans, and validation database.
• Manage validation deviations, non-conformances and change controls; drive CAPAs.
• Support audits and regulatory inspections with complete validation documentation.
• Coordinate with engineering, production, R&D and cross-functional teams on validation matters.
• Ensure validation activities comply with ISO 13485, FDA QSR 21 CFR 820, MDR and local GMP requirements.

Skills

Validation expertise

QA documentation

English proficiency

Cross-functional teamwork

Analytical skills

Education

Bachelor degree or above in Biomedical/Chemical/Mechanical Eng or related

Tools

IQ/OQ/PQ protocols

Validation database tools

Job description

• 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.

Job Summary

Job Description

Job Responsibilities

• 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.

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 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.

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.