Fresenius Medical Care

Operates dialysis facilities and renal care

Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours

Full-timeSuzhou, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

Five years of medical-device experience is desirable.
Advanced knowledge of investigations involving nonconforming products, corrective and preventive action, and complaints.
Advanced knowledge of data analysis and relevant quality statistical methods.
Advanced knowledge of medical-device regulations.
Advanced knowledge of medical-device validation.
Advanced knowledge of applicable quality-management and risk-management standards.
Knowledge of design transfer from a quality perspective.
Knowledge of internal and external processes and structures.
Ability to manage stakeholders and communicate effectively.
Ability to serve as a trusted quality partner in cross-functional project meetings.
Fluency in English.

Responsibilities

Lead investigations into nonconforming material, in-process failures, complaints, and field issues.
Support new product development and new product introduction by establishing validation and process manufacturability.
Support product transfers and process and product change notifications (design transfer).
Perform risk assessments with cross-functional teams, including process failure mode and effects analyses (pFMEAs).
Develop and implement corrective and preventive action (CAPA), and verify and validate its effectiveness.
Ensure purchased components meet specifications and quality requirements.
Participate in internal audits and support external audits.
Support complaint investigations, evaluate returned products, and implement feedback loops.
Analyze quality data, trends, and key performance indicators to drive continuous improvement.

Validation Experts
Lead investigations for nonconforming material, in-process failures, complaints and field issues
Support new product development / new product introduction to set up validation and process manufacturability
Support product transfers and process and product change notifications (design transfer)
Performs risk assessments in collaboration with cross-functional teams (pFMEAs)
Develop & implement CAPA. Verify & validate CAPA effectiveness
Ensure purchased components meet specifications and quality requirements
Participate in internal audits and support external audits
Support complaint investigations, evaluate returned products & implement feedback loops
Analyze quality data, trends, KPIs to drive CI

Job Requirements

5 years’ experience in medical device is desirable
Advance knowledge of investigation of NC, CAPA, complaint
Advance knowledge of data analysis and relative quality statistic method
Advanced knowledge of medical device regulations
Advanced knowledge of medical device validation
Advanced knowledge of applicable quality management and of risk management standards
Knowledge of the design transfer from quality aspect
Knowledge of internal and external processes and structures
Good in stakeholder management and communication
Trusted quality partner in cross-functional project meetings
Fluent in English

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size: 11-50
Company stage: Late Stage VC
Total funding: $40.2M
Headquarters: Waltham, MA
Founded: 1996

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