AnaheimRecruiter Since 2001
the smart solution for Anaheim jobs

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. , Anaheim , Quality Engineer, Biotechnology and Pharmacy , Vista, California, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Anaheim RSS job feeds