Software Quality Engineer - System Development (Business Systems Analyst, Intermediate)
Hercules, CA

Job Description

Overview

Bio-Rad Laboratories is looking for a Software Quality Engineer for its Compliance Group in IT. You'll have the opportunity to work with the best and brightest minds to advance discovery and improve lives by ensuring compliance with applicable international standards and internal policies.

Responsibilities

* Support Application teams to facilitate the SDLC process for new Applications & Systems including:
* Participate in Risk Impact Analysis for Infrastructure and Application installations and upgrades.
* Provide guidance on Quality System Regulations to define applicable requirements.
* Provide guidance and expertise on projects to meet quality system standards and internal procedural requirements, including reviewing and approving test and validation documentation.
* Work with IT personnel to improve efficiency of the SDLC/ALM processes and compliance to QSR and ISO standards.
* Apply standard CAPA techniques to evaluate and resolve issues.
* Write, update and/or review IT procedures and work instructions.

Qualifications

* Bachelor's degree or equivalent in a related life science/technical discipline.
* 6+ years' experience in a regulated industry, or equivalent combination of education and experience.
* Understanding of ISO 13485, Data Integrity, GxP and other regulatory standards as they apply to computer systems.
* Strong understanding of System Development Lifecycle, GMP and quality systems.
* Able to write clear and concise summaries of complex technical topics.
* Proficiency in Project Management, HPALM and Service Now preferred.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

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Agency Non-Solicitation:

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.