Optum Home & Community Care, part of the UnitedHealth Group family of businesses, is creating something new in health care. We are uniting industry-leading solutions to build an integrated care model that holistically addresses an individual’s physical, mental and social needs – helping patients access and navigate care anytime and anywhere.As a team member of our naviHealth product, we help change the way health care is delivered from hospital to home supporting patients transitioning across care settings. This life-changing work helps give older adults more days at home.We’re connecting care to create a seamless health journey for patients across care settings. Join us to start Caring. Connecting. Growing together.The Head of Quality will lead the establishment, implementation, and maintenance of Care Transitions’ Quality Management System (“QMS”) for our digital solutions. This individual will be a key member of the leadership team and will work effectively with cross-functional partners across the entire enterprise. The role will support our digital product evolution and new product development, assisting with the strategic roadmap and providing insight into the regulatory risks associated with different potential avenues. This individual will possess deep knowledge of the quality principles for the full Software Development Lifecyle (SDLC).Why naviHealth?At naviHealth, our mission is to work with extraordinarily talented people who are committed to making a positive and powerful impact on society by transforming health care. naviHealth is the result of almost two decades of dedicated visionary leaders and innovative organizations challenging the status quo for care transition solutions. We do health care differently and we are changing health care one patient at a time. Moreover, have a genuine passion and energy to grow within an aggressive and fun environment, using the latest technologies in alignment with the company’s technical vision and strategy.You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges.Primary Responsibilities:
Leadership
Serve as quality representative to improve awareness, visibility, and communication on quality initiatives to support the business’ quality goals and priorities
Lead regular Quality Management Reviews
Define regulatory strategies and manage regulatory submission activities for product development and product maintenance for all existing and future products
Support cross-functional teams in the development of design plans, requirements, specification development, and other activities, ensuring adherence to our QMS
Participate in and sign-off on quality support activities including design, verification and validation processes, operations/production, CAPA, and other quality systems processes & documents
Work with cross-functional partners to resolve regulatory questions from regulatory agencies
Lead, prepare, and ensure submissions are accurately prepared and compliant with applicable regulations
Work across Marketing, Sales, Legal, and others to ensure all materials accurately reflect our digital products’ intended use
QMS
Ensure compliance with all relevant quality system regulations as per 21 CFR Part 820
Develop, establish, and maintain methodologies, systems, and practices to meet quality system regulatory and customer requirements
Review and interpret regulatory requirements related to the company’s products and processes
Develop and maintain quality policies, procedures (e.g., Standard Operating Procedures), work instructions, trainings, and other documents, as needed
Manage regulatory pathways and the 510k submission process
Manage the Medical Device Reporting activities
Review and document procedure changes for quality requirements and compliance with the QMS
Support development and management of the verification/validation master plan along with verification/validation determination
Serve as the Corrective and Preventative Action (CAPA) system owner
Support necessary company registrations and certificates
Provide regulatory support for currently marketed products
Support internal and external audits
Ensure all state product registrations are maintained and renewed in a timely manner
Oversee the Regulatory Intelligence process
Other duties as assigned
You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.Required Qualifications:
8+ years of experience in a Medical Device product development environment focused on quality engineering related activities
Demonstrated experience in quality and design development systems (e.g., 21 CFR 820, IEC 62304, ISO 13485, and ISO 14971 requirements)
Experience with product and process verifications and validations
Proven solid communication skills, including the ability to simplify complex concepts and information for those less familiar
Proven good project management skills, with the ability to manage and prioritize multiple projects
Preferred Qualifications:
ASQ Software Quality Engineer certification
Experience in Software Development and Medical Device Life Cycle Management
All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter PolicyCalifornia, Colorado, Connecticut, Hawaii, Nevada, New Jersey, New York, Rhode Island, or Washington Residents Only: The salary range for this role is $104,700 to $190,400 annually. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.