SOFTWARE QA ENGINEER 3
Company: TalentBurst, Inc.
Location: Santa Clara
Posted on: January 24, 2023
Job Title: Software QA Engineer 3
Location: Santa Clara California 95051
Duration: 12 Months
Description: - -
This is not a Software testing role. This is a Software Design
Quality assurance role.
As Surgical System continues to be adopted by an increasing
population of hospitals, surgeons and patients, we are expanding
our product offering to support a more comprehensive robotic
program for our customers. As a part of this expansion this
individual will support projects that fall within a new and growing
team- Digital and data products.
As a part of this expansion, we are looking for an ideal candidate
to possesses a broad base of experience and a high level of
technical depth in individual who will be assigned to work on
digital and data software medical and non-medical products. You
will not abide "process red tape", instead passionately seek the
most efficient way to build in product quality. As part of the
role, you will work in a highly skilled, multi-disciplinary team
who you will coach, mentor, teach and influence in best software
The primary focus of this position to support design teams tasked
with development and delivery of these products from a Software
Product Quality perspective.
This is not a Software testing role. -
Roles and Responsibilities:
This person will work in a cross functional team in new product
development and/or sustaining products covering emerging
technologies in digital Health, health software, Software as
medical device (SaMD), MDDS and clinical Decision Support
This person will also support for GxP impacting software systems as
well as for Computer System in accordance with CSV/CSA
This person will serve as product quality representative for
software projects and will closely work with core team advising
others on best practices in Quality control for software centric
This person will ensure that each project is developed and released
meeting customer expectation consistent with QMS.
Participate as Quality Subject matter expert in the review of all
documents related to design control activities, providing feedback
to ensure compliance and are audit ready before approving them.
Author Master Validation Plan (MVP), Master Validation Report
(MVR), Device performance summary report and procedure
Participate in ongoing implementation of the Quality Management
System (QMS) in conformance with US FDA Quality System Regulations,
21 CFR 820, ISO 13485, IEC 62304 and Computer system assurance
Supports the risk management activities for software in compliance
with ISO 14971 and Guides software development teams on
cybersecurity Risk management activities in accordance with NIST
Primary Quality Lead in review of Design History file for
completeness and adequacy at design reviews.
Provide inputs to GxP assessments for 21 CFR part 11/data integrity
Able to articulate the latest and complex regulation to project
Able to understand the impact of regulations to our procedures and
make the corresponding SOP/DOP updates. -
Able to contribute to external audits, perform internal audits.
Assist with developing procedures when new digital products are
design and developed in accordance with regulatory requirements and
Expected to work independently, holding him/herself accountable to
proactively fulfill tasks and achieve results within assigned
Skills, Experience, Education, & Training:
Required: Education- 4-year degree in software, Biomedical,
electrical, mechanical or system engineering or equivalent
technical discipline. Advanced degree is also preferred.
Required: 5+ years' experience in Software Design/ Quality
Hands on experience with ISO 62304, medical device software Life
Working knowledge on 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part
11, GAMP5, electronic record and electronic signature
Experience in training, working collaboratively with software
Experience with digital health or digital IT.
Experience in GxP computer systems
Experience working on low and high-risk software applications using
a scalable approach to the SDLC practices and the QMS.
Attention to details and Quality are critical to success.
Excellent organizational, interpersonal, and verbal and written
communication skills, with the ability to deliver quality outputs
under minimum supervision.
Keywords: TalentBurst, Inc., Santa Clara , SOFTWARE QA ENGINEER 3, IT / Software / Systems , Santa Clara, California
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