Unique opportunity to work across all Mazor Robotics' product platforms and to optimize and maintain key processes leading to our world-class robotics systems. This position has the responsibility and authority to work under general guidance to support the design, development, test and market release of software products used in medical devices: surgical robotics, navigation applications and other.
Key Responsibilities & Authorities:
• Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, work closely with R&D to develop appropriate qualifications, verifications, validations, and non-product software, for both new design and changes to released product.
• Perform Quality Engineering support for projects in Design Controls processes, including, but not limited to plan, requirements, V&V protocol and report review/approval, risk management, requirements management and trace matrix.
• Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate engineering methods and techniques.
• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System regarding software and system design.
• Support software defects process uncovered during development, testing and post-release.
• Provide solutions to a wide range of challenges. Work to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Follow all Quality System Practices as defined by Mazor Robotics practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO, EU and other global quality standards and regulations are met where applicable.
• Training and educating on design controls best practices and SOPs (Including Templates and checklists).
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Establishes/Participates in the documentation strategy planning and execution.
• Perform DHF audits.
• Lead problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.
• Ensure documentation and findings are completed in a timely manner and in compliance with FDA, European, and other relevant Regulatory agency standards and procedures; recommend and implement actions or changes to improve quality.
• B.Sc./B.A. in Engineering or similar related field.
• At least two (2) years' experience in the medical device industry, Design Controls focused.
• Advance knowledge with Medical Device Quality Systems, ISO 13485:2003, CFR21 Part 820, EU Medical Device Directive, ISO 14971, ISO 62366 and ISO 62304 standards.
• DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the product development lifecycle.
• Good ability to comprehend multi-disciplinary systems and processes
• Excellent verbal, written and communication skills.
• Advantage –front/back room participation in Design Controls audits