Software Quality Engineer - Planet Pharma : Job Details

Job Description 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. Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.