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Quality Engineer - (Complaint Handling)

LanceSoft INC
Pleasanton, California, United States
April 27, 2018

The Quality Analyst – Post Market Vigilance will review, evaluate, and investigate product complaints relative to the identity, quality, safety, and effectiveness of medical products. The Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations. Duties also include compliance tracking, trend analysis, and reporting to Management.

Primary Duties:

- Using your working knowledge and understanding of the US FDA regulations for Class I, II, and III medical devices regarding Medical Device Reports (MDRs), Adverse Drug Events (ADE's) and complaint handling and reporting.

- Utilizes detailed understanding of the clinical environment and the use of medical devices, to determine if complex and/or new reported issues and complaints are reportable based on FDA and International regulations.

- Drafts professional quality and timely written communication including documentation of events and findings, customer communications, procedures, and risk based analyses.

- Acts as a mentor and leader within the department providing guidance and assistance to Analyst I’s and II’s.

- Demonstrates detailed knowledge of medical devices, Quality Assurance concepts and procedures.

- Handles and processes potentially contaminated complaint samples using appropriate PPE Independently scopes, retrieves, reviews, trends, analyzes and reports data using spreadsheets, graphs, and databases.

- Interacts daily with customers via telephone and written correspondence regarding post market issues.

- Communicates in professional and courteous manner.

- Develops, Prepares, and Presents training materials.

Experience & Knowledge


- Bachelors’ degree in engineering or science or relevant experience with an Associate’s degree in clinical/medical discipline

- Medical device experience

- 3-5 years related experience in post-market vigilance/surveillance/complaints with medical devices.

- CAPA, MDR, and ADE reporting experience required.

- Regulatory and Quality Management knowledge and skills

- Knowledge of Bio-Hazardous Materials and related safeguards and protocols.


This individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective