Quality Assurance Engineer - Plano, TX - UnitedHealth Group

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)

The Quality Assurance Engineer will be responsible for supporting with quality engineering duties with a strong background in regulatory compliance in accordance with 21 CFR Part 820 and ISO 13485:2016.    

Primary Responsibilities

• Assist and support in activities to establish and maintain a comprehensive Quality Management System that meets all applicable FDA Medical Device regulations and ISO standards.

• Assist in the monitoring of regulatory adherence across departments with respect to new product development, labeling and marketing material review, vendor management, process improvement.

• Lead the investigation, resolution, and prevention of supplied component nonconformances.  Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Support with Complaint Handling, Design Controls – for new devices, Process improvements, and more.  Work with Contract Manufacturing for process improvement projects.

• Perform Internal Audits

• Support with filing MDRs to FDA; must have experience with medical device industry.

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:

• High School Diploma / GED or higher

• Five (5) or more years of 21 CFR Part 820 Medical Device experience

• Two (2) or more years of experience with Complaint Handling and MDRs filing with FDA

• Five (5) or more years of direct, hands-on experience working with a Quality Management System

• Two (2) years of technical writing skills, problem solving skills, project management skills

• Two (2) or more years of New Product Development – Design Controls experience, Process Improvement and Process Validation experience.   IQ/OQ/PQ protocol development.

• 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:

• CQE and/or Six Sigma Blackbelt

• Two (2) or more years of Supplier Quality Management experience

•  Bachelor’s degree in mechanical or biomedical engineering

Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)

UnitedHealth Group requires all new hires and employees to report their COVID-19 vaccination status.

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: #RPO, healthcare, UHG, quality management, quality assurance, medical device, technical writing, project management, process improvement, product development, Plano, TX, Texas