Software QA (Product & Regulatory)

  • PhysIQ
  • Two Prudential Plaza, 180 N Stetson Ave #2400, Chicago, IL 60601, USA
  • Nov 09, 2020
[Information Technology]

Job Description

PhysIQ is looking for a Software QA Engineer is engaged in the product development and regulatory process. The job involves ensuring the quality of a Software as a Medical Device (SaMD) product throughout the requirement, engineering, V&V (Validation and Verification), and release phases. The role requires performing and documenting components of the quality assurance tasks, conforming to the organizations quality management system (QMS).


Hands-on Engineering to solve problems and provide solutions

Review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable.

Define test methods and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements.

Execute test plans and create test reports to describe program evaluation, testing, and correction (i.e., validation activities).

Identify, record, document thoroughly and track bugs.

Recommend design improvements or corrections to engineers throughout the development process.

Identify and utilize existing testing tools that facilitate data gathering and test method execution.

Track quality assurance metrics, like defect densities and open defect counts.

Participate in complaints / nonconformance / CAPA team meetings with Product, Quality, and Customer Success functional areas.

Assist in establishing and measuring compliance with organizations quality management system including audit scheduled tasks, audit preparation, and internal audit execution.

Bridge responsibilities in ensuring adequate risk assessment of software products and traceability with design control.

Required Skills

Bachelors Degree in electrical engineering, Computer engineering or equivalent technical Degree; or equivalent combination of education and experience.

Excellent analytical skills.

High level of initiative with ability to self-manage.

Strong interpersonal skills with ability to work both independently and as part of a team.

Excellent written and verbal communication skills.

Two (2) years Quality functional area experience in medical device industry preferred.

Functional knowledge of FDA regulations (21 CFR 820; Quality System Regulation) and appropriate industry standards for quality (ISO13485), life-cycle (IEC62304), and Risk Management (ISO14971) preferred.

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Associated topics: automation, prevent, quality assurance, quality assurance analyst, quality assurance engineer, quality assurance lead, software quality, software quality assurance engineer, test, test engineer