Combine two of the fastest-growing fields on the planet with a culture of performance, collaboration and opportunity and this is what you get. Leading edge technology in an industry that's improving the lives of millions. Here, innovation isn't about another gadget, it's about making health care data available wherever and whenever people need it, safely and reliably. There's no room for error. Join us and start doing your life's best work.(sm)
Primary Responsibilities:

• Substantial experience assisting companies with FDA compliant QMS systems including in-depth understanding of FDA Quality System Regulations, ISO 13485 and ISO 14971
• Support the maintenance and continuous improvement of the quality management system processes
• Experience with FDA inspections; Participate in external audits
• Perform all formal responsibilities of a Lead Auditor such as audit team selection; audit planning; conducting opening and closing meetings and daily debriefs with management; completing an audit report and issuing, reviewing, and approving formal corrective actions with collaboration and support from Quality and Regulatory leadership
• Analyze audit performance to identify trends, risks, and opportunities for continuous improvement; recommend and facilitate improvement initiatives and actions
• Support the implementation of quality system processes, including but not limited to Non-Conformance, CAPA, complaint handling, internal/external audits, and training
• Prepare reports by collecting, analyzing, and summarizing data regarding quality processes/product capabilities, problems and trends, and quality related design & development activities
• Lead CRB process and provide status updates to senior leadership
• Provide support with preparing Quality metrics reporting for management review meetings
• Promote effective and timely resolution to quality problems with the focus on true root cause and verified corrective action
• Review and recommend improvements to the Quality Management System

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 (engineering preferred) or equivalent experience
• 3+ years of experience in an FDA requlated industry (medical device or pharmaceutical)
• 3+ years of experience working with FDA Quality System Regulations
• 2+ years of experience with CAPA and complaint handling
• Full COVID-19 vaccination is an essential requirement of this role. UnitedHealth Group will adhere to all federal, state and local regulations as well as all client requirements and will obtain necessary proof of vaccination prior to employment to ensure compliance

Preferred Qualifications:

• Internal audits experience
• Leadership/mentoring experience

To protect the health and safety of our workforce, patients and communities we serve, UnitedHealth Group and its affiliate companies now require all employees to disclose COVID-19 vaccination status prior to beginning employment. In addition, some roles require full COVID-19 vaccination as an essential job function. UnitedHealth Group adheres to all federal, state and local COVID-19 vaccination regulations as well as all client COVID-19 vaccination requirements and will obtain the necessary information from candidates prior to employment to ensure compliance. Candidates must be able to perform all essential job functions with or without reasonable accommodation. Failure to meet the vaccination requirement may result in rescission of an employment offer or termination of employment.
Technology Careers with Optum. Information and technology have amazing power to transform the health care industry and improve people's lives. This is where it's happening. This is where you'll help solve the problems that have never been solved. We're freeing information so it can be used safely and securely wherever it's needed. We're creating the very best ideas that can most easily be put into action to help our clients improve the quality of care and lower costs for millions. This is where the best and the brightest work together to make positive change a reality. This is the place to do your life's best work.(sm)
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.
Job Keywords: Senior Quality Systems Engineer, Quality Systems Engineer, Plano, TX, Texas