1+ months

Senior Quality Engineer - Plano, TX - 930331

Plano, TX 75074
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  • Job Code
    930331

Energize your career with one of Healthcares fastest growing companies.

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You dream of a great career with a great company where you can make an impact and help people. We dream of giving you the opportunity to do just this. And with the incredible growth of our business, its a dream that definitely can come true. Already one of the worlds leading Healthcare companies,

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UnitedHealth Group is restlessly pursuing new ways to operate our service centers, improve our service levels and help people lead healthier lives. We live for the opportunity to make a difference and right now, we are living it up.

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This opportunity is with one of our most exciting business areas:Optum a growing part of our family of companies that makeUnitedHealth Groupa Fortune 6 leader.

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Optumhelps nearly 60 million Americans live their lives to the fullest by educating them about their symptoms, conditions and treatments; helping them to navigate the system, finance their healthcare needs and stay on track with their health goals. No other business touches so many lives in such a positive way. And we do it all with every action focused on our shared values of Integrity, Compassion, Relationships, Innovation & Performance.

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Senior Quality Engineer partners with colleagues from across Vivify to assist in compliance activities of the quality system and participate in continuous improvement activities.

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Primary Responsibilities:

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  • Support with Complaint Handling, CAPA, Internal Audits, Design Controls, Process improvements, and more. Works with Contract Manufacturing Engineering to assess and address QMS gaps.
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  • Drives the development, maintenance and improvement of quality of components sourced from outside suppliers.
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  • Supplier Quality Agreements - Leads in the evaluation and development of Supplier Agreements with suppliers.
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  • Develops all supplied component quality plans to drive component qualification,
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  • Manages development of supplied product inspection procedures/first article requirements.
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  • Assesses supplier capabilities through direct visits, technical discussions, Collaborates with suppliers to develop comprehensive process validation strategies.
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  • Proactively communicates quality issues to suppliers as needed through supplier corrective action requests and technical discussions.
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  • Leads the investigation, resolution and prevention of supplied component nonconformances. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues..
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  • Mitigates risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
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  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
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  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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  • Performs other related duties and responsibilities as assigned
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Youll 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.

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Required Qualifications:

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  • Bachelor's degree in a related area or equivalent combination of education and work experience
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  • 5+ years of related work experience with a strong understanding of Quality Engineering (documented success will be required)
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  • You will be asked to perform this role in an office setting or other company location.
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  • Employees are required to screen for symptoms using the ProtectWell mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or a similar UnitedHealth Group-approved symptom screener prior to entering the work site each day, in order to keep our work sites safe. Employees must comply with any state and local masking orders. In addition, when in a UnitedHealth Group building, employees are expected to wear a mask in areas where physical distancing cannot be attained.
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Preferred Qualifications:

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  • Bachelor's or master's degree in one of the following Engineering disciplines: Electrical, Bio-medical, or Mechanical
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  • 6+ years of relative professional work experience in Medical Device Quality or in automotive industry
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  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
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  • Six Sigma Black Belt
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  • Strong knowledge of electromechanical processes and products
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"Soft Skills:

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  • Excellent verbal and communication skills
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  • Detail - oriented with strong organizational skills
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  • Ability to work interdepartmentally
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  • Must possess the ability to solve practical problems or root cause analysis with a variety of specific variables in situations where only limited standardization exists
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UnitedHealth Group is an essential business.The health and safety of our team members is our highest priority, so we are taking a science driven approach to slowly welcome and transition some of our workforce back to the office with many safety protocols in place. We continue to monitor and assess before we confirm the return of each wave, paying specific attention to geography-specific trends. We have taken steps to ensure the safety of our 325,000 team members and their families, providing them with resources and support as they continue to serve the members, patients and customers who depend on us.

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You can learn more about all we are doing to fight COVID-19 and support impacted communities:click here.

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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.

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UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

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Keywords: Senior Quality Engineer, Plano TX, Supplier Quality, hiring immediately, #RPO

Posted: 2021-05-15 Expires: 2021-07-14

UnitedHealth Group is the most diversified health care company in the United States and a leader worldwide in helping people live healthier lives and helping to make the health system work better for everyone.

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Senior Quality Engineer - Plano, TX - 930331

UnitedHealth Group
Plano, TX 75074

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