Job Description

Key Responsibilities:

• Execute testing of electrical, mechanical, and software components and systems as applicable.
• Follow test protocols; execute testing; complete verification and validation activities
• Assist in identifying, recommending, implementing, managing, and administering process and software validation.
• Participate in internal and external audits.

We’re Looking For:

• 3+ years’ experience in Quality assurance including medical device design controls.
• Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
• Solid understanding of IEC 62304 Medical Software Development Process
• Familiarity with Risk Management standards ISO 14971
• Excellent analytical and decision-making skills, as well as strong written and verbal communication
• Ability to speak effectively before groups of clients or employees.
• Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus.
• Experience in modern test automation is a plus.

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