Quality Engineer – Quality Management System – Remote

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. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.

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

Primary Responsibilities:

• Establish and maintain a fit for purpose Quality Management System in line with the applicable medical device regulations and industry standards
• Observe and impact analyze upcoming changes in relevant regulations, standards, guidance and corporate processes
• Administer electronic Quality Management software supporting the management of the Quality Management System
• Develop and deploy the trainings on Quality Management System, standards, best practices and electronic Quality Management software
• Maintain product line’s audit schedule
• Conduct internal quality audits
• Ensure timely identification and completion of corrective & preventive actions
• Work closely with cross functional teams to promote a culture of quality and safety within the product line
• Analyze process quality metrices, report and escalate the deviations to all relevant stakeholders for timely interventions
• Collaboration with cross-functional teams in activities not limited to supplier quality management, product risk management and handling of complaints

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:

• 7+ years of experience in the medical device industry
• Hands-on experience in authoring processes and maintaining a Quality Management System
• Proven knowledge of the FDA Quality System Regulation (QSR) and the international standard ISO 13485:2016
• Proven ability to multi-task and prioritize responsibilities
• Proven excellent attention to detail
• Proven excellent verbal and written communication
• Proven creative problem-solving skills
• Proven data analysis and statistical aptitude
• Proven good interpersonal skills

Preferred Qualifications:

• ASQ Software Quality Engineer certification
• Demonstrated experience in software quality and design development systems (e.g., 21 CFR 820, Medical Device Directive, ISO 13485, IEC 62304, and ISO 14971 requirements)
• Experience in Clinical Decision Support, Software as Medical Device and Medical Device Life Cycle Management
• Experience in lean methodologies like Value Stream Mapping
• Experience with electronic Quality Management Software

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

California, Colorado, Connecticut, Hawaii, Maryland, Nevada, New Jersey, New York, Rhode Island, Washington, Washington, D.C. Residents Only: The salary range for this role is $88,000 to $173,200 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.