Quality Management Engineer - Design Controls - National Remote

Lensa; United States; Remote; USD 89,000 - 177,000; Full time

Job summary

Join a forward-thinking organization dedicated to advancing health equity globally. As a Quality Management Engineer, you will play a pivotal role in ensuring the implementation of a fit-for-purpose Quality Management System. Collaborate with cross-functional teams while enjoying the flexibility of remote work. You'll be at the forefront of developing innovative clinical solutions that improve health outcomes. This role offers a dynamic environment where your contributions will directly impact communities and foster a culture of quality and safety. Embrace the opportunity to grow professionally and make a meaningful difference.

Benefits

Comprehensive benefits package

Incentives

Stock options

401k

Qualifications

• 5+ years of experience with Software as Medical Device (SaMD).
• 3+ years of experience with FDA QSR 21 CFR 820 and ISO 13485.

Responsibilities

• Ensure adherence to relevant regulations and quality processes.
• Guide product team in establishing and maintaining the Design History File.
• Develop and manage quality plans for products.

Skills

Software as Medical Device (SaMD)

FDA QSR 21 CFR 820

ISO 13485

IEC 62304

Agile development

Data analysis

Problem-solving

Communication

Leadership

Attention to detail

Education

High School Diploma/GED

Bachelor’s Degree in Engineering, Computer Science, IT, or Biomedical Sciences

Job description

Quality Management Engineer - Design Controls - National Remote

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Lensa is the leading career site for job seekers at every stage of their career. Our client, UnitedHealth Group, is seeking professionals. Apply via Lensa today!

Optum, a global organization, delivers care aided by technology to help millions live healthier lives. Your work with our team will directly impact health outcomes by connecting people with the care, pharmacy benefits, data, and resources they need. We foster a culture of diversity and inclusion, talented peers, comprehensive benefits, and career development opportunities. Join us to make an impact on communities as we advance health equity globally. Start Caring. Connecting. Growing together.

Optum is redefining how consumers and business customers interface with healthcare products and services. Critical to this are the innovative products developed by the newly formed Optum Insight Clinical Decision Support (CDS) team. The mission of the OI CDS team is to deliver clinical solutions that achieve the quadruple aim and build trust with users.

The Quality Management Engineer – Design Controls will be key in ensuring the OI CDS team implements a 'fit for purpose' Quality Management System. You will collaborate with cross-functional teams to ensure timely activities across the software product lifecycle, including implementing design controls, analyzing product quality metrics, supporting risk analysis, complaint monitoring, and training.

We seek someone with experience in Software as Medical Device, a business-oriented approach, and pragmatic problem-solving skills.

You will enjoy the flexibility to telecommute* from anywhere within the U.S. while tackling challenging projects.

Primary Responsibilities

• Ensure adherence to relevant regulations, standards, and quality processes
• Guide product team members in establishing and maintaining the Design History File (Engineering File)
• Develop and manage quality plans for products
• Review engineering deliverables and provide feedback
• Conduct milestone reviews
• Support product risk analysis, evaluation, control, residual risk assessment, and post-market monitoring
• Assist in complaint monitoring and tracking
• Develop and deliver training on relevant quality topics
• Participate in corrective and preventive actions and quality audits
• Drive process improvements collaboratively
• Promote a culture of quality and safety within the product line
• Analyze product quality metrics, report deviations, and escalate issues

You will be recognized and rewarded for your performance in an environment that challenges you, provides clear success criteria, and offers development opportunities.

Required Qualifications

• High School Diploma/GED or higher
• 5+ years of experience with Software as Medical Device (SaMD)
• 3+ years of experience with FDA QSR 21 CFR 820, ISO 13485, IEC 62304

Preferred Qualifications

• Bachelor’s Degree in Engineering, Computer Science, IT, or Biomedical Sciences
• Experience with EU MDR, ISO 14971
• Experience in Agile development and medical device lifecycle management
• Experience with Clinical Decision Support and SaMD
• ASQ Software Quality Engineer certification
• Hands-on experience implementing quality systems
• Strong multitasking, attention to detail, communication, problem-solving, data analysis, and leadership skills

The salary range is $89,800 to $176,700 annually, based on full-time employment and various factors. Benefits include comprehensive packages, incentives, stock options, and 401k. All telecommuters must adhere to UnitedHealth Group’s Telecommuter Policy.

We consider qualified applicants with arrest or conviction records, respecting the San Francisco Fair Chance Ordinance.

Application Deadline: Posted for at least 2 business days or until a sufficient candidate pool is reached. Early removal possible due to volume.

UnitedHealth Group’s mission is to help people live healthier lives and improve the health system for everyone. We are committed to equity, diversity, and environmental sustainability, addressing health disparities and promoting equitable care.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Opportunity Employer and a drug-free workplace. Candidates must pass a drug test before employment.