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Sr. Quality Engingeer- Software as a Medical Device

Company: Livongo Health, Inc.
Location: Mountain View
Posted on: September 14, 2023

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 PositionUnder the leadership of the Manager of Quality Assurance, the Sr. Quality Engineer is responsible for providing Quality leadership 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.Role and Responsibilities* Contributing to product design with respect to the following principles: design control, change control, risk management, human factor engineering, process validation, and supplier management, and software development lifecycle (SDLC)* Supporting with 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 execute on design development plans, risk management plans, V&V plans, product test cases, trace matrices, labeling, etc.* Working with Product and Technology teams to continuously streamline the design and development processes, enabling Teladoc Health to deliver safe and effective new products to members as quickly as possible* Leading risk management activities for both new design and product/process changes* Providing quality engineering support during development and sustaining of new product designs and production processes, demonstrating regulatory compliance and adherence to internal QMS requirements* Reviewing and providing feedback on project decisions and deliverables* Ensuring that design and/ or production process changes made with suppliers are vetted for potential product performance impact* 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* Providing Quality and compliance input for post-market activities, such as hardware changes and software updates, review of customer complaints, and CAPAs* Partnering with department and project leaders in developing and reporting appropriate performance and Quality metrics* Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues* Supporting internal and external audits* Other duties as appropriate to support product quality goals and the requirements of the QMS* Traveling domestically or internationally 1 to 2 times per yearQualifications* Bachelor of Science in Engineering - preferably software, mechanical, or electrical engineering* Minimum of 2 years of Quality or Engineering experience in the medical device industry* Experience with Quality Management Systems including: 21 CFR 820 and ISO 13485* Demonstrated experience with ISO 14971 required* Experience in interacting with Notified Bodies and Regulatory agencies, including FDA preferred.* Passion for finding new, innovative, non-traditional methods for accomplishing goals* Knowledge of medical device design controls, experience in both hardware (IEC 60601 or IEC 61010) and software development (IEC 62304) preferred* Ability to work in a cross-functional team environment, building rapport and influencing decisions across all levels of the organization* Excellent written, verbal and presentation skills required, including the ability to communicate clearly, succinctly, effectively, and remotely* Enthusiasm for teamwork and collaboration, with limited supervision* 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* Flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events* Skill at managing competing demands, with the ability to change approach or method to best fit the situationThe base salary range for this position is $90,000 - 110,000. In addition to a base salary, this position is eligible for performance bonus, RSU's, and benefits (subject to eligibility requirements) listed here: Teladoc Health Benefits 2023. 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-JS3#HybridWhy 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.

Keywords: Livongo Health, Inc., Mountain View , Sr. Quality Engingeer- Software as a Medical Device, Healthcare , Mountain View, California

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