Quality Engineer

6 days ago

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Teladoc Health

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telemedicine • physician cross-coverage • online doctor consultation • electronic medical records • interactive health tools

5001 - 10000

Description

• Collaborating with cross-functional teams to support medical device product development • Supporting the design, development, commercialization, and post-launch of devices • Owning risk management activities for new designs and changes • Providing quality engineering support and guidance independently • Reviewing and providing feedback on project decisions and deliverables • Supporting Supplier Quality and Supply Chain activities requiring Quality guidance • Applying systematic problem-solving methodologies in quality issue resolution

Requirements

• Bachelor of Science in Engineering – preferably software, mechanical, electrical, or biomedical engineering • Minimum of 2 years of Quality or Engineering experience in the medical device industry • Experience with Quality Management Systems including: 21 CFR 820 and ISO 13485 preferred • Demonstrated experience with ISO 14971 preferred • Experience in interacting with Notified Bodies and Regulatory agencies, including FDA preferred. • Knowledge of medical device design controls, experience in both hardware (IEC 60601 or IEC 61010) and software development IEC 62304 is preferred • Excellent written, verbal and presentation skills required, including the ability to communicate clearly, succinctly, effectively, and remotely • Ability to strictly follow policies and procedures when required • Flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events • Skill at managing competing demands, with the ability to change approach or method to best fit the situation

Benefits

• performance bonus • insurance • stock options • Teladoc Health Benefits 2024