Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Come make an impact on the communities we serve as we help advance health equity on a global scale. Here, you will find talented peers, comprehensive benefits, a culture guided by diversity and inclusion, career growth opportunities and your life's best work.(sm)

The Quality Systems Director will be accountable for leading the establishment, implementation, and maintenance of the site cGMP compliance activities for Clinical Decision Support applications and platforms within the Center for Advanced Clinical Solutions. The role will require application of quality principles for the full Software Development Lifecyle (SDLC) by internal business stakeholders.

You’ll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges.

Primary Responsibilities:

• Develop, establish, and maintain methodologies, systems and practices to meet quality system regulatory and customer requirements
• Develop and maintain quality policies, procedures (e.g., Standard Operating Procedures), work instructions, and other documents and training as needed
• Review and document procedure changes for quality requirements and compliance with the quality system
• Lead quality engineering support activities including design, verification and validation processes, operations/production, CAPA, DME, DMF and other quality systems processes & documents
• Drive quality in all project deliverables and ensure that development teams follow processes that are effective and compliant to Standard Operating Procedures
• Serve as quality representative to improve awareness, visibility, and communication on quality initiatives to support business quality goals and priorities
• Provide Quality project management support for product development to production
• Provide Quality engineering support for product development, complaints and sustained product improvements
• Support development and management of the verification/validation master plan along with verification/validation determination
• Corrective and Preventative Action (CAPA) system owner or support of the corrective action system and procedures
• Run regular Quality Management Reviews
• Support cross-business functional development teams to assist in the development of design plans, requirements, specification development, and other activities as needed
  

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:

• Undergraduate degree or equivalent experience
• Bachelor’s degree of Engineering or Science or equivalent degree
• 8+ years of experience in a Medical Device/Combination product manufacturing/product development environment focused on quality engineering related activities
• Demonstrated experience in quality and design development systems (e.g., 21 CFR 820, Medical Device Directive, ISO 13485, IEC 62304, and ISO 14971 requirements)
• Experience/knowledge with product/process verifications/validations

Preferred Qualifications:

• Master’s degree or above
• ASQ Software Quality Engineer certification
• Experience in Clinical Decision Support tools
• Experience in Software Development and Medical Device Life Cycle Management
• Good project management skills and initiative in taking on and completing projects
• Good verbal and written communication skills
• Ability to manage and prioritize multiple projects/objectives
• Solid interpersonal, teamwork, and communication skills
• Solid written communication demonstrating the ability to simplify complex information

UnitedHealth Group is working to create the health care system of tomorrow.

Already Fortune 5, we are totally focused on innovation and change. We work a little harder. We aim a little higher. We expect more from ourselves and each other. And at the end of the day, we're doing a lot of good.

Through our family of businesses and a lot of inspired individuals, we're building a high-performance health care system that works better for more people in more ways than ever. Now we're looking to reinforce our team with people who are decisive, brilliant - and built for speed.

Come to UnitedHealth Group, and share your ideas and your passion for doing more. We have roles that will fit your skills and knowledge. We have diverse opportunities that will fit your dreams.

Careers with Optum. Our objective is to make health care simpler and more effective for everyone. With our hands at work across all aspects of health, you can play a role in creating a healthier world, one insight, one connection and one person at a time. We bring together some of the greatest minds and ideas to take health care to its fullest potential, promoting health equity and accessibility. Work with diverse, engaged and high-performing teams to help solve important challenges.

Colorado, Connecticut, Nevada, or New York City Residents Only: The salary range for Colorado residents is $113,500 to $218,100. The salary range for Connecticut/Nevada/New York City residents is $113,500 to $218,100. Pay is based on several factors including but not limited to education, work experience, certifications, etc. 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.

*All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy

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.