Compliance Team, Inc. is a leading provider of quality technical consulting services and resources to our strategic partners in the pharmaceutical, biotechnology, and medical device industries. Whether we are asked to provide an entire team or an individual, our professionals consistently provide quality oversight of operations, review for accuracy, completeness, and conformance to current good manufacturing practices (cGMP), company quality standards, and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.
We are seeking a Software QA Product Engineer who would be responsible for managing and overseeing all aspects of the lifecycle of commercial software products from idea through obsolescence. Works closely with cross-functional teams to analyze, develop, launch, improve and maintain software products that solve business problems.
1. Define and prioritize the development and implementation of impactful software product visions, roadmaps, and strategies.
2. Participate in cross-functional projects to develop product software including user requirements, design specifications, traceability matrixes, software configuration, testing, verification, and validation.
3. Actively participate in an Agile product development process environment, including developing effective customer-focused user stories and leading the prioritization of products and features.
4. Manage or assist in new product launches including product positioning, sales training, beta/pilot programs and marketing communications.
5. Develop SOWs and bids for software development proposals to customers.
6. Provide input on product design and architecture and interpret research reports on products, market segments and emerging technologies.
7. Participate in efforts to resolve software issues and meet business requirements by working with end-users, information systems staff, software vendors and service providers.
8. Participate in efforts with business areas and information system staff to configure and manage software systems in development, test and production environments as part of the software lifecycle.
9. Analyze, design, develop, document, test, implement, support and maintain software systems.
10. Perform software design and code reviews for other developers.
1. Support other cross-functional business areas by providing input and analysis related to position.
2. Provide off-hours and business hour product support as required.
3. Perform other duties as assigned.
1. Bachelor's degree in computer science or information technology.
2. Minimum 5 - 8 years’ experience in a formal software development role, preferably supporting product software, with experience in developing and executing system test plans.
3. Experience with leading cross-functional, self-governed teams.
4. Knowledge of regulations and standards affecting IVDs or other regulated products.
5. Knowledge of product development processes including design control for IVDs.
6. Ability to communicate and negotiate effectively with several levels of co-workers and external contacts, both in writing and verbally.
7. Ability to effectively and efficiently prioritize multiple projects and resources based on an awareness of business goals and revenue targets in a rapidly advancing market.
1. MBA or equivalent desired.
2. Business fundamentals in strategy, financial analysis and planning, including SWOT analyses and problem solving, data evaluation, recommendation and action plans.
1. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, and protective gloves).
2. Ability to use computers in an interactive manner for extended periods of time.
3. Ability to travel up to 10% of the time.
The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.