- Assumes responsibility for initiating and performing defined quality activities leading to new or improved processes or systems on a program level.
- Usually reports to a quality supervisor or senior technical individual.
- As a Quality Validation Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
- Implementing risk-based validation approach to ensure IT (GxP) software and applications comply with regulations and industry guidelines
- Developing and executing software validation projects to meet validation deliverables
- Facilitating the resolution of key quality validation issues by assisting in failure investigations, assisting in problem resolution, and providing feedback to IT development and infrastructure teams.
- Interpretating the quality requirements including verification/validation planning, execution, and problem resolution.
- Supporting audits as a technical subject matter expert for software and application validation.
- Supports audits performed governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits.
- Reviews and approves updates to quality system and IT validation documents.
- Interacting frequently with Quality, Information Technology, Manufacturing, R&D Validation and Verification laboratory and other business units to support project and objective completion.
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conforms to, supports, and enforces all Company policies and procedures.
- To set you up for success in this role from day one, Client requires (at a minimum) the following qualifications:
- Bachelor's degree or higher in a Science or Engineering (computer science, mechanical engineer, chemical engineer, industrial engineer, or engineering Science) discipline from an accredited institution
- 3 years experience in computer system validation for medical device industry
- Experience with Waterfall, Agile and Scrum methodologies
- Demonstrated skill in project management, coordinating project resources and schedules
- Experience creating test scripts, created test plans and implement tests plans.
- Master's degree or higher in a Science or Engineering (mechanical engineer, chemical engineer, industrial engineer, or engineering Science) discipline from an accredited institution
- Quality Systems experience (CAPA, non-conformances, deviations, etc) and/or software validation experience
- Demonstrated successful interactions with cross-functional project teams
- Solutions-oriented and skills/knowledge to manage complex problems and projects
- Use of IT validation eTools (i.e., JIRA, qTest, electronic record approval systems)
- Ability to work with minimal guidance and manage project deliverables and timelines
- Minimal work direction needed, highly skilled and knowledgeable to the position and provides best practicing sharing within work group.
- Works with client to analyze and define the business process that needs an IT solution.
- Identifies and documents high-level requirements, maps future state of the solution, and ensures the system/solution meets business and user requirements.
- Document and map business process and requirements for the future state of the IT solution
- Identify and understand the end user's need
- Facilitate the business process redesign and documentation as needed
Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.
In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact firstname.lastname@example.org.
All applicants applying must be legally authorized to work in the country of employment.
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