Quality Device & Software Manager - Medical Devices

Brief:

Novodes invites applications for the role of Quality Device & Software Manager - Medical Devices in an ongoing collaboration with a multinational medical device company. This role is based at the client's offices in Rehovot, near the train station, and offers hybrid working conditions with two days of remote work each week.

Department: Quality

Reports To: Director of QA Device

Primary purpose and function of this position:

The Quality Device & Software Manager will support 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 lifecycle of medical devices, software, and applications.

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

Primary 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 the System team to allow synchronization between the teams

• Review and approve device, software, and cybersecurity documents and validation protocols/reports as a quality representative to ensure compliance with company 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 has 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 in quality assurance related to software development)

• 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 multitask, prioritize, and work effectively under pressure.

• Excellent oral and written communication skills in English.

Travel Requirements: As Required

About Novodes:

• As a leading contract development firm, Novodes specializes in software development services for the medical device industry, providing turnkey solutions to a broad range of clients, from startups to NASDAQ-listed companies.