Software Quality Engineer

Contract Length: 2 years

Candidates local to Austin, TX are strongly preferred

Experience: General medical device experience—training will be provided on internal/homegrown systems. This is a junior-level role (2-5 years)

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. Ensures that all areas outlined under “Principal Responsibilities” are accomplished in an efficient and professional manner to support a medical device client.

Qualifications
· Minimum of a Bachelors 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 company 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.
PRINCIPAL 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.
· Effectively complete “other” functions that may be assigned.