Failure Analysis Technician

Philips•Bothell, WA

1d•Onsite

About The Position

The Failure Analysis Technician is responsible for performing analysis on returned devices related to complaint allegation of malfunction, analyzing the process for improvements. Your role: Performs failure analysis on returned devices related to complaint allegations. Works with limited supervision, escalating issues to superiors as needed and develops a substantial understanding of relevant regulations, requirements, and standards. Aids to implement procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good documentation practices (GDP). Provides support towards the execution of validation protocols and failure analysis testing methods for new products and processes. Engages in continuous learning and on-the-job training to enhance skills and knowledge and ensures quality of own work by conducting checks and taking responsibility for the accuracy of work.

Requirements

2+ years of experience in Quality Control with medical device or a regulated industry, preferred.
Proficiency in Good Documentation Practices (GDP).
General understanding of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).
Technical Diploma, or Bachelor or Associates Degree in engineering science, or equivalent work experience.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Responsibilities

Performs failure analysis on returned devices related to complaint allegations.
Works with limited supervision, escalating issues to superiors as needed and develops a substantial understanding of relevant regulations, requirements, and standards.
Aids to implement procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good documentation practices (GDP).
Provides support towards the execution of validation protocols and failure analysis testing methods for new products and processes.
Engages in continuous learning and on-the-job training to enhance skills and knowledge and ensures quality of own work by conducting checks and taking responsibility for the accuracy of work.