Quality Engineer

Teladoc Health is a global, whole person care company made up of a diverse community of people dedicated to transforming the healthcare experience. As an employee, you're empowered to show up every day as your most authentic self and be a part of something bigger - thriving both personally and professionally. Together, let's empower people everywhere to live their healthiest lives.

Under the leadership of the Manager of Quality Assurance, the Quality Engineer is responsible for providing Quality input and collaborating with Operations, Engineering, Product, Supplier Quality, Supply Chain, Member Quality, and Regulatory to support and drive product development, risk management, supplier management, and compliance to internal and external requirements.

Must be willing to work on-site, this is not a remote position, 2 days per week minimum in Office.

Contributing to New Product Development with respect to the following principles: design control, risk management, Verification and Validation activities, human factor engineering, process validation, supplier management, and software development lifecycle (SDLC) for Software as Medical Device (SaMD) with sufficient analytical and technical acumen in Quality Engineering.

Supporting the design, development, commercialization, and post-launch (full product life‑cycle) of electro‑mechanical, digital health, and/or diagnostic devices.

Working closely with Product and Technology teams to create and/or execute on design development plans, trace matrices, Cybersecurity requirements, risk management plans, V&V protocols and reports, product test cases, labeling, etc., and provide quality guidance in Design & Development deliverables.

Providing quality engineering support and guidance independently during development and sustaining of new product designs and production processes, demonstrating regulatory compliance and adherence to internal QMS requirements. Applying sound, systematic, technical problem‑solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues. Reviewing and providing feedback independently on project decisions and deliverables.

Owning risk management activities for both new design and product/process changes.

Supporting Supplier Quality and Supply Chain activities that require Quality guidance, assessing impacts on supplier changes in design and/or production processes, reviewing and approving BOM, labeling, supplier validations, Design History File, Device Master Record documentations.

Performing external standard review as applicable.

Providing Quality and compliance input for post‑market activities, such as hardware changes and software updates, review of customer complaints, and CAPAs.

Other duties as appropriate to support product quality goals and the requirements of the QMS.

Supervisory Responsibilities

No

Bachelor of Science in Engineering - preferably software, mechanical, or electrical, or biomedical engineering.

Minimum of 2 years of Quality or Engineering experience in the medical device industry.

Required Experience with Quality Management Systems including: 21 CFR 820 and ISO 13485, ISO 14971, and IEC 62304.

Drive to meet deadlines and achieve or exceed goals and expectations. Ability to strictly follow policies and procedures when required, while also knowing when to think outside the box.

Ability to work in a cross‑functional team environment, building rapport and influencing decisions across all levels of the organization. Flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events.

Excellent written, verbal and presentation skills required, including the ability to communicate clearly, succinctly, effectively, and remotely.

Experience in Process Improvement to continuously streamline the design and development processes.

Experience in interacting with Notified Bodies and Regulatory agencies, including FDA preferred. Experience with supporting internal and external audits.

Experience with IEC 60601 or IEC 61010 compliant devices is…