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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.
Location: Remote
Work Schedule: Mon - Fri (2pm to 11pm IST)
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.
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
Required Qualifications
- Bachelor of Science in Engineering – preferably software, mechanical, or electrical, or biomedical engineering
- At least 3 to 5 years of experience in Quality or Engineering roles within 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 supporting 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.
As part of our hiring process, we verify identity and credentials, conduct interviews (live or video), and screen for fraud or misrepresentation. Applicants who falsify information will be disqualified.
Teladoc Health will not sponsor or transfer employment work visas for this position. Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
Why join Teladoc Health?
Teladoc Health is transforming how better health happens. Learn how when you join us in pursuit of our impactful mission.
Chart your career path with meaningful opportunities that empower you to grow, lead, and make a difference.
Join a multi-faceted community that celebrates each colleague’s unique perspective and is focused on continually improving, each and every day.
Contribute to an innovative culture where fresh ideas are valued as we increase access to care in new ways.
Enjoy an inclusive benefits program centered around you and your family, with tailored programs that address your unique needs.
Explore candidate resources with tips and tricks from Teladoc Health recruiters and learn more about our company culture by exploring #TeamTeladocHealth on LinkedIn.
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). In our innovative and inclusive workplace, we prohibit discrimination and harassment of any kind.
Teladoc Health respects your privacy and is committed to maintaining the confidentiality and security of your personal information. In furtherance of your employment relationship with Teladoc Health, we collect personal information responsibly and in accordance with applicable data privacy laws, including but not limited to, the California Consumer Privacy Act (CCPA). Personal information is defined as: Any information or set of information relating to you, including (a) all information that identifies you or could reasonably be used to identify you, and (b) all information that any applicable law treats as personal information. Teladoc Health’s Notice of Privacy Practices for U.S. Employees’ Personal information is available at this link.
