Software Quality Engineer

ClinLab Staffing; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in the FDA regulated industry is seeking a Quality Engineer to provide support in software validation and quality assurance. The role requires a bachelor's degree in Software Engineering, with a focus on maintaining compliance and improving product quality. Candidates should have a minimum of 2 years of relevant experience, ideally in the pharmaceutical or medical device sectors, proficient in quality systems and regulatory requirements.

Qualifications

• 2 years of hands-on experience in FDA-regulated industries.
• In-depth knowledge of current Good Manufacturing Practices and Quality System Regulations.
• Experience in software validations and developing report packages.

Responsibilities

• Manage software project scheduling and resource requirements.
• Develop and document software validations to ensure product reliability.
• Review requirements documentation for accuracy and verifiability.

Skills

Quality Engineering

Quality Assurance

Software Validation

Communication

Education

Bachelor's degree in Software Engineering or Computer Science

Job description

Position Objective:

This position utilizes Quality Engineering and Quality Assurance techniques and expertise to provide functional support for new product development and product line support. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities:

Review IT Application Change Requests to assess impact of the change and determine software verification/validation strategies.

Manage Software project scheduling and resource requirements.

Assist in the development of project schedules, including the identification of project tasks and associated timelines.

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

Assist in discussions with IT to evaluate system interfaces, operational requirements, and performance requirements of overall system.

Define test scripts and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.

Recommend design improvements or corrections to the User and/or IT throughout the development process.

Maintain effective communication with the User and IT on project limitation, capability, performance requirement and hardware interface changes.

Manage the implementation of off-the-shelf software programs.

Define process requirements that align with industry best practices and regulatory guidance to aid in data gathering and test method execution.

Support manufacturing during the implementation of software used in production.

Develop, conduct, and document software validations to ensure products processed are proven to be reliable, safe, and effective prior to release.

Assess equipment changes for software validation needs.

Coordinate software validation activities, and scheduling, in support of corporate projects.

Represent the Corporation and Quality Department in a professional manner.

Qualifications:

Minimum of a bachelor's degree in an Software Engineering, Computer Science field or equivalent experience.

Minimum 2 years hands-on experience; preferably in an FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.

Specific experience with software validations, as well as developing report packages, to approve equipment, processes, and software used in the receipt, testing, processing, storing, and distribution of raw materials, components, and tissues/products.

Ability to understand Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.

ASQ CQE/CQA or other Software Certification preferred but not required.