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Quality Engineer

Quality Engineer

Teladoc HealthLewisville, TX, United States
11 hours ago
Job type
  • Full-time
Job description

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.

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.

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

Essential Duties and 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

Supervisory Responsibilities

No

Qualifications Expected for Position

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

Preferred Qualifications :

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 .

The base salary range for this position is$80,000 - $90,000 . 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 2025 .Total compensation is based on several factors including, but not limited to, type of position, location, education level, work experience, and certifications.This information is applicable for all full-time positions.

#LI-Hybrid

Why Join Teladoc Health?

A New Category in Healthcare : Teladoc Health is transforming the healthcare experience and empowering people everywhere to live healthier lives.

Our Work Truly Matters : Recognized as the world leader in whole-person virtual care, Teladoc Health uses proprietary health signals and personalized interactions to drive better health outcomes across the full continuum of care, at every stage in a person's health journey.

Make an Impact : In more than 175 countries and ranked Best in KLAS for Virtual Care Platforms in 2020, Teladoc Health leverages more than a decade of expertise and data-driven insights to meet the growing virtual care needs of consumers and healthcare professionals.

Focus on PEOPLE : Teladoc Health has been recognized as a top employer by numerous media and professional organizations. Talented, passionate individuals make the difference, in this fast-moving, collaborative, and inspiring environment.

Diversity and Inclusion : At Teladoc Health we believe that personal and professional diversity is the key to innovation. We hire based solely on your strengths and qualifications, and the way in which those strengths can directly contribute to your success in your new position.

Growth and Innovation : We've already made healthcare yet remain on the threshold of very big things. Come grow with us and support our mission to make a tangible difference in the lives of our Members.

As an Equal Opportunity Employer, we never have and never will discriminate against any job candidate or employee due to age, race, religion, color, ethnicity, national origin, gender, gender identity / expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status, parental status or pregnancy.

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Quality Engineer • Lewisville, TX, United States

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