Operations & Quality Systems Improvement Experts

Job Summary:
Operations & Quality Systems Improvement Experts (OQSIE) is a company focused on improving operational and quality systems. They are seeking a Software Validation Engineer to provide validation support for medical products and software used in manufacturing and quality systems, actively participating in the product development cycle and ensuring compliance with validation guidelines.
Responsibilities:
• Provide software validation support and guidance to Smith & Nephew's ASD division for applications developed by S&N for medical products, or software used by S&N's manufacturing and quality systems.
• Be part of a team that is actively involved in the product development cycle, from an early design stage, by helping define or update user needs and software requirements specifications, and participating in product risk assessments, code and design reviews and developing the set of software validation documents.
• Be responsible for auditing software applications and supporting multiple S&N locations.
• Follow the guidelines of the corporate validation policy and inform management whenever changes are needed to a software validation.
Qualifications:
Required:
• Minimum of Bachelor's degree in Computer Science, Engineering, Science, or equivalent.
• Experience with software validation – for both product and non-product software – in the medical device industry and knowledge of FDA software validation guidelines; Experience with IQ, OQ, and PQ for software validations is required
• Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques
• Develop and document software validation protocols, document software errors and anomalies
• Working knowledge of application software development lifecycle, and understanding of functional testing methodologies (white box, black box, positive, negative, boundary, and regression)
• Create and update Standard Operating Procedures (SOPs) and other software validation-related system design documents
• Working knowledge of the development of medical devices in conformance with Quality System Regulations, IEC 62304, IEC 62366, ISO13485, and ISO14971 standards
Company:
OQSIE is an execution-based consulting company with a focus in Life Sciences. Founded in 2013, the company is headquartered in Irvine, USA, with a team of 11-50 employees. The company is currently Early Stage.