Overview

This position will be responsible for concurrent software quality engineering activities associated with new product development, business / quality systems and risk management. Primary responsibility will be to handle quality engineering duties in the following areas of software development and computer systems: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability.

Responsibilities

• Ensure defendable software engineering and scientific analyses are employed on assigned projects.
• Provide software engineering services to new product development projects such as, use engineering, systems engineering, specification setting, defect resolution and essential design elements.
• Design experiments and conduct investigations to identify root cause of problems and implement effective corrective actions.
• Lead initiatives in process or product improvement areas.
• Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution.
• Develop QMS processes through cross-functional teams

• Bachelors Degree (B.S.) in computer science, systems engineering, or related degree (or other technical degree applicable to position being filled) or related discipline from an accredited university and significant related experience
• Strong working knowledge of software development life cycle models within a complex hardware/software development system.
• Broad experience in the application of design controls and risk management in an IVD or Device industry.
• Outstanding interpersonal and communication skills and ability to develop cross functional partnerships.
• Experience in the application of production and process controls including process validation, process control plans and statistical process control.
• Good understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971, BS EN 62304, 62366). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820.
• Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
• Experience representing their department during quality system audits.