Quality Engineer

Teladoc Health • Lewisville, TX

13d • $80,000 - $90,000 • Hybrid

About The Position

Join the team leading the next evolution of virtual care. At Teladoc Health, you are empowered to bring your true self to work while helping millions of people live their healthiest lives. Here you will be part of a high-performance culture where colleagues embrace challenges, drive transformative solutions, and create opportunities for growth. Together, we’re transforming how better health happens. Summary of Position 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. Candidate must be willing to work on-site, this is not a remote position, 2 days per week minimum in Office at one of the following Teladoc locations: Chicago, IL, Goleta, CA, Lewisville, TX, San Jose, CA.

Requirements

• 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 , 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 , including the ability to communicate clearly, succinctly, effectively, and remotely

Nice To Haves

• 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 s upporting internal and external audits .
• Experience with IEC 60601 or IEC 61010 compliant devices is preferred
• Experience with assessing design and/ or production process changes made with suppliers are vetted for potential product performance impact
• Partnering with department and project leaders in developing and reporting appropriate performance and Quality metrics .
• Passion for finding new, innovative, non-traditional methods for accomplishing goals .
• Skill at managing competing demands, with the ability to change approach or method to best fit the situation .
• Enthusiasm for teamwork and collaboration, with limited supervision .
• Traveling domestically or internationally 1 to 2 times per year .

Responsibilities

• 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

Benefits

• In addition to a base salary, this position is eligible for a performance bonus and benefits (subject to eligibility requirements) listed here: Teladoc Health Benefits 202 6 .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees