Quality Engineer
Company: Leica Biosystems Imaging, Inc.
Location: Vista, California
Posted on: February 26, 2018
Job Description:
Will provide Quality Engineering support for software and
hardware development projects. Will provide risk assessment and hazard
analysis deliverables and assist the team in Design History file
completion and approval. Will provide review and guidance for verification
and validation activities related to the Digital pathology
development projects for image acquisition, image processing, image analysis
and Information management systems. Will work with management and
technical staff in the manufacturing function in the performance of root
cause failure analysis, as well as identification and implementation
of corrective and preventive actions to preclude recurrence of
identified issues. Education and Experience: Master’s degree (or foreign education equivalent) in
Biomedical Engineering, Medical Imaging, or related field and • three (3) years of experience performing in a quality engineering role in FDA regulated medical device or IVD
industry environment; leading Hazard Analysis and Risk Management
activities; assisting subject matter experts in the development of
process/product validations, test method validations, design controls,
software verification, and validation testing; and providing guidance in
Agile Scrum methodologies and Software Development Lifecycle. • three (3) years of experience interpreting and applying requirements defined within ISO 13485, 21 CFR 820, ISO 14971,
and IEC 62304. • two (2) years of experience utilizing field feedback data (including customer complaints) to drive product
improvement. OR Bachelor’s degree (or foreign education equivalent) in
Biomedical Engineering, Medical Imaging or related field and • five (5) years of experience performing in a quality
engineering role in FDA regulated medical device or IVD industry
environment; leading Hazard Analysis and Risk Management activities;
assisting subject matter experts in the development of process/product validations, test method validations, design controls,
software verification, and validation testing; and providing guidance in
Agile Scrum methodologies and Software Development Lifecycle. • five (5) years of experience interpreting and applying requirements defined within ISO 13485, 21 CFR 820, ISO 14971,
and IEC 62304. • two (2) years of experience utilizing field feedback data (including customer complaints) to drive product
improvement. Submit resume to LBS-PI@leicabiosystems.com; Reference Code:
“LeicaGS”.
Keywords: Leica Biosystems Imaging, Inc. , San Diego , Quality Engineer, Biotechnology and Pharmacy , Vista, California, California
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