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Job Category:

Business Operations



Approximate Salary:

Not Specified

Position Type:

Full Time

Regional Quality Process Engineer - CA or TX

UHG - Carlsbad, California

Posted: 11/12/2018

The Regional Quality Process Engineer is responsible for fulfilling the role of a residential hands-on quality expert that ensures the quality of product produced at OptumRx Pharmacies meets customer expectations. Primarily responsible for evaluating and modifying new and existing processes and manufacturing systems to reduce cost, improve sustainability, and develop best practices within the assigned regional pharmaceutical sites. The Process Engineer will focus on improving production rates, efficiencies, yields, and costs while maintaining or improving quality. Oversight includes process excellence support for existing products including supply chain, production and post-production processes; development and trending of quality metrics, compliance and control. Quality Engineering training with statistics, validation, knowledge of compounding (USP 795/797 requirements), filling (aseptic / non-sterile) and packaging processes within the pharmaceutical industry.
Primary Responsibilities:
  • Proactively identifying opportunities across a region of pharmacies to continuously improve our products and processes and assess for regulatory, quality, ergonomic, safety, environmental, and cost impacts
  • Innovative and passionate about developing, supporting and improving manufacturing processes for products and processes that are the highest quality in their class; always keeping the consumer in line of sight
  • Championing new equipment/process development with appropriate process validations
  • Collaborating with system’s engineers to ensure product fitness for use requirements are effectively translated into process controls and testing requirements
  • Planning and executing technical work using statistical techniques including Designing of Experiments, Evaluating the Measurement Procedure, and Statistical Process Control
  • Conducting failure analysis and root cause understanding
  • Championing effective project practices, documentation and reviews
  • Drives DPPM reduction by leading cause analysis for process/product variability and driving quality improvements for elimination of special causes, waste, and reduction of variability
    - Apply a working knowledge of quality principles and statistics to assigned processes and products
    - Lead effective root cause analysis / corrective action through use of cause mapping, process mapping, fishbone diagrams, etc.
    - Develop test methods
    - Effectively identify, troubleshoot and resolve non-routine problems
    - Ability to lead continuous improvement efforts that will enable our production operations to continuously run to target, reduce variability, and consistently produce quality products for our customers
    - Identify and drive process improvement projects leading to annualized hard savings
  • Providing floor personnel guidance and support to control the quality of the work
  • Initiating design, validation, defect classification and documentation reviews as required
  • Identifying and capturing hard savings improvements for elimination of waste: Overproduction, Backlog, Maintenance costs, Downtime, Packaging Costs, Defects (Scrap, rework, delays), Transport & Handling, Processing
  • Using solid knowledge of engineering fundamentals and the proven ability to apply this knowledge in manufacturing and process improvements and new process development
  • Using working knowledge of statistical tools such as designed experimentation, process validation and/or statistical process control for manufacturing processes
  • Working effectively in team situations as well as independently
  • Effectively influencing site operations, regulatory associates; product specialists; technical and plant leadership, as well as external suppliers
  • Developing new processes from pilot phase to commercial scalability
  • In-depth knowledge of sterilization process development and validation; knowledge of ANSI/AAMI/ISO sterilization standards; computer systems and manufacturing processes
  • A broad and comprehensive understanding of Quality Systems, regulatory requirements, OSHA, and GMP 
  • Demonstrating knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes  
  • Motivated and energized by collaborating on a cross functional, cross-regional team and recognize the importance of building and maintaining strong interpersonal relationships
  • Motivated by the challenge of troubleshooting technically complex product and process issues; change agent

Required Qualifications:
  • Bachelor’s Degree or higher in science or engineering discipline from an accredited university
  • Certified Quality Engineer (CQE)
  • 6+ years of related work experience with exposure to medical product or regulated process mature environment (FDA, FAA)
  • 6+ years of related work experience with USP standards 795/797 and clean room requirements (testing, monitoring and controlling)
  • 6+ years of quality engineering experience with regional responsibility
  • 6+ years of experience with: Industrial Engineering, Manufacturing, Systems Integration, Supply Management; healthcare desirable in combination with business process improvement, process engineering experience
  • Knowledge of FDA, cGMP, ISO and Clean Room standards
Preferred Qualifications:
  • Design for Reliability and Manufacturing (DRM) experience

Careers with OptumRx. We're one of the largest and most innovative pharmacy benefits managers in the US, serving more than 12 million people nationwide. Here you’ll fill far more than prescriptions. As a member of one of our pharmacy teams, you’re empowered to be your best and do whatever it takes to help each customer. You'll find unrivaled support and training as well as a wealth of growth and development opportunities driven by your performance and limited only by your imagination. Join us. There's no better place to help people live healthier lives while doing 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: Regional Quality Process Engineer 

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