New

Sr. Quality Assurance Specialist

Teladoc Health
United States, Texas, Lewisville
1945 Lakepointe Drive (Show on map)
May 22, 2025
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 In your role as Senior Quality Assurance Specialist, you will work cross-functionally with Production, Supply Chain, Customer Support teams on a diverse medical product portfolio, exploring exciting new fields such as in-vitro diagnostic devices, mobile medical apps, and Software as a Medical Device (SaMD). You will support Teladoc Health product design, release and distribution while assuring compliance and quality excellence. You'll create work instructions, guidance documents for quality operation, review records pertaining to medical device production and subsequently release products to the market. In addition, you'll be responsible for a variety of related Quality Assurance duties, as you contribute to Returned Device Inspection, Document Changes and related activities. Essential Duties and Responsibilities Essential duties for the position including requirements, tasks, work to be complete * Conduct Initial Functional Testing on returned medical device. Manage returned complaint investigation metrics. Escalate investigation results when the new failures are confirmed. * Perform other testing and inspection activities as required, including product return analysis * Review Device History Records (DHRs), assuring compliance with product specifications and company traceability requirements * Verify that Teladoc Health medical devices are manufactured in accordance with the Device Master Record (DMR) * Document and record results of all product review findings, using appropriate data sheets and forms * Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, Product, Tech, Supply Chain, etc.) * Collaborate with appropriate technical, clinical, sales and/or returned product analysis employees to determine reporting eligibility * Ensure compliance with the company's Quality Management System policies, procedures and applicable external requirements/standards, including FDA, ISO13485, and other worldwide regulatory agencies * Participate in continuous-improvement activities for the Quality Management System * In cases of product non-conformity or design deviation, ensure that these deviations have not negatively impacted product function and quality * In cases of product non-conformity or design deviation, ensure that deviations have full approval and are documented in the DHR * Perform Product Release after completion of DHR reviews * Review the DHR to support complaint investigations * Maintain and update a status report for product returns, pending device evaluations, and investigations * Assist in the analysis and trending of post-market surveillance data * Support Document Change activities as needed * Assist with other projects and duties as needed The time spent on each responsibility reflects an estimate and is subject to change dependent on business needs. Supervisory Responsibilities No Qualifications Expected for Position Those qualification needed such as certification, training, experience, or knowledge skills * 5+ years' experience as a Quality Assurance professional * Experience in a regulated product manufacturing environment * Experience performing device history record (DHR) reviews (lot/batch record review) and component/product release activities * A proven track record of meeting deadlines * Proficiency with microscopes, conventional handheld device inspection tools (e.g.calipers, micrometers, gage blocks, etc.), and other related tools * Demonstrated ability to effectively work cross-functionally with other departments including Operations and Product Development * The ability to interface with both technical and non-technical personnel at all organizational levels * Proficiency with Microsoft Office * Speed and proficiency when learning new skills, policies and corporate systems * Demonstrated interpersonal, written and oral communication skills * The versatility to adapt to changing priorities and workflow for multiple projects and deadlines * Demonstrated enthusiasm for working with a sense of urgency * The ability to safely lift items weighing 20-50 pounds * Prior experience with QA for medical devices preferred Required license or credential needed to perform job: N/A The above qualifications, knowledge, experience, and/or background are expected but not required for this role Travel: 10% Travel percentage reflects an estimate and is subject to change dependent on business needs. Physical Requirements To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. Teladoc Health will make reasonable accommodation for the known physical or mental limitations of an otherwise qualified individual in line with company policy. About Us Teladoc Health is the global virtual care leader, offering the only comprehensive virtual care solution spanning telehealth, expert medical, and licensed platform services. Teladoc Health serves the world's leading insurers, employers, and health systems and helps millions of people around the world resolve their healthcare needs with confidence. Job Description Acknowledgment This job description is a general overview of the nature and level of work performed by employees with this job designation. It is not intended to be a comprehensive list of all duties, responsibilities and qualifications required for this position. Management reserves the right to add, delete, and/or modify any of the job duties or requirements at any time. I acknowledge that I have read and understand the above job description. By signing this job description, I understand the duties that are expected of me. The base salary range for this position is$50,000 - $60,000.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. 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.