Engineer III, S/W QA

Job Description

Purpose Statement: Provide Software Quality Assurance support, to corporate software policies and regulations, at the Penang site. Provides support on software validation requirements to project teams that are implementing software systems and provides an independent review to teams. Key Responsibilities: Develop an in-depth knowledge of BSC s policies and procedures, especially those that apply to BSCs software. Understand and be able to explain how these policies achieve compliance with appropriate regulations and standards. Be able to interpret policies and regulations in support of a wide variety of software such as Custom, Off-The-Shelf, as well as everything from equipment controllers to database-driven solutions. Apply these policies and procedures to the site s software systems and computer-driven equipment. Be able to explain software validation deliverables to business owners of the applications. Ability to perform risk analysis on multiple systems. Create validation documentation for a wide range of software applications including equipment software. Provide guidance and direction on the acceptability of Software Quality deliverables, based on requirements and templates given. Requirements: Bachelors (or higher) degree in engineering with preference Computer Science. 5-7+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation. Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning - resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in ISO 62304