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:

• Managing the overall performance of the quality department
• Ensuring compliance with FDA regulations
• Establish the quality management system and procedures
• Plan and conduct internal quality audits
• Identify potential sources of error and suggest ways to eliminate them. (Preventive Actions)
• Facilitate CAPA Review Board Meetings; Support with CAPA activities including investigation, implementation of corrective actions, monitoring of effectiveness checks including statistical techniques
• Coordinate efforts among different departments within an organization
• Compile quality information needed for the management review
• Annual evaluations of subordinates' performances
• Effectively manage overall complaint handling process; must have experience with Medical device industry complaint handling; requires deep understanding of requirements around complaint handling and resolution
• Identify opportunities for process improvement and develop best practice approach to make it more efficient
• Monitor complaints for adverse trends and escalate critical issues in a timely manner
• Experience with MDR Reporting for serious injury complaints
• Collaborate with Clinical and Product team, Contract manufacturing for in-depth investigations
• Provide audit support as subject matter expert on complaint handling system
• Prepare quality metrics and present to senior leadership during monthly meetings
• other duties as assigned
• Review documents prepared and submitted by suppliers and contractors
• Periodic evaluations of suppliers' performances
• Support the supplier performance improvement process
• Responding to client complaints related to the product quality, conducting the root cause analysis and taking necessary corrective actions

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
• 3+ years of experience in an FDA regulated industry (medical devices or pharmaceutical)
• 2+ years of experience with Complaint Handling and Quality Engineering
• 2+ years of experience in Quality Engineering leadership
• 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:

• Undergraduate degree in Engineering
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 and 820, ISO 13485 and Canadian Regulations
• Proven ability to multi-task and seamlessly manage personnel for timely handling of complaints
• Able to communicate precisely and accurately to all levels of the organization
• Solid analytical, critical thinking skills

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: Manager, Quality Engineering, Complaint Handling, Plano, TX, Texas