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Teladoc Health · 8 hours ago

Quality Engineer

Lewisville, TX

Full-time

Hybrid

Entry, Mid Level

$80K/yr - $90K/yr

2+ years exp

Teladoc Health is a leader in virtual care, empowering employees to contribute to transformative health solutions. The Quality Engineer will collaborate with various teams to ensure quality input in product development, risk management, and compliance, while supporting the full product life-cycle of medical devices.

Health CareMental HealthmHealthPrimary and Urgent CareTelehealthWellness

No H1B

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

Qualification

Quality Management SystemsMedical Device IndustryRisk ManagementVerificationValidationEngineering DegreeProcess ImprovementRegulatory ComplianceCommunicationTeam CollaborationProblem Solving

Required

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

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