Quality Device & Software Manager

Primary purpose and function of this position:

Quality Device & Software Manager will support the Device and software development projects and documentation required for FDA and EU-MDR device approval. The individual will work as a principal member of sustaining and new product development team(s), while collaborating across the different disciplines within the company.

Act as Software Quality Engineer responsible for various software quality assurance functions during the development’s lifecycle of medical devices, software and application

The Software Quality Manager position is responsible for various software quality assurance functions during the development lifecycle of medical devices. In addition, the position is responsible for advancing best practices and ensuring that the software development process is followed. This includes identifying and mitigating risks appropriately.

Major duties and responsibilities:

• Support development projects as a design quality assurance applying design control methodology to achieve product quality in compliance with regulatory requirements

• Interface with R&D, SW development and system to allow synchronization between the teams

• Review and approve device, software and cybersecurity documents and validation protocols/reports as quality representative to ensure compliance with compony procedures and design control requirements.

• Provide QA guidance on design, software and technical and engineering processes/documentation to ensure compliance with applicable standards

• Participate in design, requirements, risk analysis, CVSS and software design reviews and ensure risks are appropriately mitigated.

• Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, internal/external audits, or other duties as assigned.

Competencies:

• Solution-oriented and problem-solving attitude.

• Strong communication and organizational skills.

• Strong project leadership and motivation skills.

• Punctual, meets deadlines and self-learning capabilities.

• Team players who can also operate autonomously.

Education and Knowledge Requirements:

• Eng. degree or higher degree in Software, Mechanics, Biomed, Electronics or a science related field.

• More than 5 years of professional experience in medical device development (Experience quality assurance)

• Experience in design and software Validation, Process Validation and Change Control Process.

• Strong working knowledge of quality systems such as IEC 62304, 60601, ISO 13485, 21 CFR 820, ISO 14971 and EU-MDR.

• Excellent communication skills.

• Expertise in critical thinking, influence, innovation, negotiation, problem solving and strategic planning skills.

• Demonstrated ability to multi-task, prioritize and work effectively under pressure.

• Excellent oral and written communication skills in English.