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Software Design Quality Engineer

Santa Clara, CA
Amick Brown is seeking an experienced Software Design Quality Engineer for our direct client.
Location: Santa Clara, CA
Duration: 11 Months

Description
  • This is not a Software testing role. This is a Software Design Quality assurance role.
  • As our clients 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 Quality practices.
  • 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 (CDS).
  • This person will also support for GxP impacting software systems as well as for Computer System in accordance with CSV/CSA guidelines.
  • 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 products.
  • 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 deviations.
  • 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 principles.
  • 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 guidelines.
  • 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 requirements.
  • Able to articulate the latest and complex regulation to project team.
  • 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 guidance’s.
  • Expected to work independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.

Required Skills
  • 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 Engineering.
  • Hands on experience with ISO 62304, medical device software Life Cycle process
  • 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 development teams.
  • 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.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits: 
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs




 

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